Susceptibility Test Discs, Antimicrobial
FDA product code JTN · Class II (moderate risk) · 21 CFR 866.1620 · Microbiology
331510(k) clearances
0PMA approvals
46recalls
Manufacturers
- Hardy Diagnostics 84
- Bd Becton Dickinson Vacutainer Systems Preanalytic 43
- Difco Laboratories, Inc. 41
- Oxoid , Ltd. 31
- Investigacion Farmaceutica S.A. DE C.V. 19
- Pasco Laboratories, Inc. 16
- Remel Co. 14
- General Diagnostics 12
- Becton Dickinson Microbiology Systems 12
- Unipath , Ltd. 10
- Organon Teknika Corp. 8
- Becton Dickinson & Co. 7
- Oxoid Limited (Part of Thermo Fisher Scientific) 7
- Becton, Dickinson and Company 4
- Warner-Lambert Co. 4
- Liofilchem, Inc. 3
- Remel, L.P. 3
- Thermo Fisher Scientific (Oxoid Ltd.) 3
- Adams Scientific, Inc. 2
- Giles Scientific, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10)JTN · Traditional | Hardy Diagnostics | 08/20/2026SE |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 07/24/2026SE |
| K261853 | Gepotidacin GEP 10 µgJTN · Traditional | Liofilchem, Inc. | 07/23/2026SE |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | Hardy Diagnostics | 05/11/2026SE |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 12/05/2025SE |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | Hardy Diagnostics | 11/20/2025SE |
| K251879 | Sulopenem SPM 2 µgJTN · Traditional | Liofilchem | 08/12/2025SE |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | Hardy Diagnostics | 06/26/2025SE |
| K250885 | Ceftobiprole BPR 5 µg DiscJTN · Traditional | Liofilchem, Inc. | 06/23/2025SE |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 06/12/2025SE |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)JTN · Traditional | Hardy Diagnostics | 05/15/2025SE |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | Hardy Diagnostics | 07/18/2024SE |
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5JTN · Traditional | Oxoid Limited (Part of Thermo Fisher Scientific) | 03/22/2024SE |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20JTN · Traditional | Oxoid Limited (Part of Thermo Fisher Scientific) | 10/06/2023SE |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)JTN · Traditional | Hardy Diagnostics | 07/06/2023SE |
| K230651 | BD BBL Sensi-Disc Lefamulin 20µg (LMU-20)JTN · Traditional | Becton, Dickinson and Company | 06/07/2023SE |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5)JTN · Traditional | Hardy Diagnostics | 06/01/2023SE |
| K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)JTN · Traditional | Becton, Dickinson and Company | 12/21/2022SE |
| K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30JTN · Traditional | Oxoid Limited (Part of Thermo Fisher Scientific) | 09/15/2022SE |
| K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20JTN · Traditional | Oxoid Limited (Part of Thermo Fisher Scientific) | 10/27/2021SE |
| K203700 | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30JTN · Traditional | Oxoid Limited (Part of Thermo Fisher Scientific) | 07/30/2021SE |
| K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20JTN · Traditional | Oxoid Limited (Part of Thermo Fisher Scientific) | 12/04/2020SE |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30)JTN · Traditional | Hardy Diagnostics | 01/23/2020SE |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20)JTN · Traditional | Hardy Diagnostics | 09/19/2019SE |
| K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)JTN · Traditional | Hardy Diagnostics | 07/31/2019SE |
| K183298 | HardyDisk AST Omadacycline 30µg (OMC30)JTN · Traditional | Hardy Diagnostics | 01/18/2019SE |
| K181975 | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30JTN · Traditional | Oxoid Limited (Part of Thermo Fisher Scientific) | 09/27/2018SE |
| K182357 | HardyDisk AST Eravacycline 20µg (ERV20)JTN · Traditional | Hardy Diagnostics | 09/26/2018SE |
| K181700 | HardyDisk AST Plazomicin 30ug (PLZ30)JTN · Traditional | Hardy Diagnostics | 07/10/2018SE |
| K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)JTN · Traditional | Hardy Diagnostics | 10/03/2017SE |
| K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5)JTN · Traditional | Hardy Diagnostics | 08/01/2017SE |
| K170127 | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40JTN · Traditional | Hardy Diagnostics | 03/14/2017SE |
| K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40JTN · Traditional | Hardy Diagnostics | 11/24/2015SE |
| K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50JTN · Traditional | Hardy Diagnostics | 11/24/2015SE |
| K152516 | BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test DisksJTN · Traditional | Becton, Dickinson and Company | 10/13/2015SE |
| K112586 | Ceftaroline 30 Micrograms, Bbl(Tm) Sensi-Disc(Tm)JTN · Traditional | Becton, Dickinson and Company (BD) | 10/18/2011SE |
| K103538 | Hardydisk Ast Ceftaroline, 30 Ug Model Z939JTN · Traditional | Hardy Diagnostics | 12/17/2010SE |
| K100722 | Telavancin 30 Ug, BBL Sensi-DiscJTN · Traditional | Becton, Dickinson and Company | 03/29/2010SE |
| K093807 | Hardydisk Ast TELAVANCIN,30UGJTN · Traditional | Hardy Diagnostics | 01/08/2010SE |
| K082271 | Fluconazole 25UG BBL Sensi-DiscJTN · Traditional | Becton, Dickinson & CO | 10/06/2008SE |
| K082272 | Voriconazole 1UG BBL Sensi-DiscJTN · Traditional | Becton, Dickinson & CO | 10/02/2008SE |
| K080998 | Doripenem 10UG BBL Sensi-DiscJTN · Traditional | Becton, Dickinson & CO | 05/12/2008SE |
| K080019 | Hardydisk Ast Doripenem 10 UgJTN · Traditional | Hardy Diagnostics | 01/29/2008SE |
| K070262 | Ertapenem Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 03/14/2007SE |
| K062245 | Hardy Disk Ast Tigecycline 15 Ug, MODELZ936JTN · Traditional | Hardy Diagnostics | 08/23/2006SE |
| K060286 | Tigecycline Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 03/17/2006SE |
| K052853 | Tigecycline 15UG BBL Sensi-DiscJTN · Traditional | Becton, Dickinson & CO | 11/17/2005SE |
| K052876 | Telithromycin 15UG BBL Sensi-DiscJTN · Traditional | Becton, Dickinson & CO | 11/14/2005SE |
| K050062 | Gemifloxacin, 5UG BBL Sensi-DiscJTN · Traditional | Becton, Dickinson & CO | 02/10/2005SE |
| K042157 | Daptomycin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 09/14/2004SE |
| K020842 | Ertapenem 10UG BBL Sensi-DiscJTN · Traditional | Becton, Dickinson & CO | 05/15/2002SE |
| K011384 | Hardydisk Novobiocin, 30MCG, Model Z883JTN · Traditional | Hardy Diagnostics | 06/13/2001SE |
| K011385 | Hardkydisk Neomycin, 30 MCGJTN · Traditional | Hardy Diagnostics | 05/18/2001SE |
| K011086 | Hardydisk Bacitracin, 10MCG, Model Z927JTN · Traditional | Hardy Diagnostics | 04/26/2001SE |
| K010537 | Linezolid Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 04/24/2001SE |
| K010536 | Moxifloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 04/24/2001SE |
| K003690 | Hardydisk SulfisoxazoleJTN · Traditional | Hardy Diagnostics | 01/25/2001SE |
| K003554 | Hardydisk Trimethoprim 5MCGJTN · Traditional | Hardy Diagnostics | 01/19/2001SE |
| K003556 | Hardydisk Amoxicillin/Clavulanic Acid, 20/10MCGJTN · Traditional | Hardy Diagnostics | 01/17/2001SE |
| K003686 | Hardydisk Ticarcillin/Clavulanic Acid, 85MCGJTN · Traditional | Hardy Diagnostics | 01/12/2001SE |
| K003537 | Hardydisk Rifampin, 5MCGJTN · Traditional | Hardy Diagnostics | 01/12/2001SE |
| K003536 | Hardydisk Nafcillin, 1 MCGJTN · Traditional | Hardy Diagnostics | 01/12/2001SE |
| K003532 | Hardy Disk, Cefpodoxine, 10MCGJTN · Traditional | Hardy Diagnostics | 12/13/2000SE |
| K002662 | Hardydisk Clindamycin, 2MCGJTN · Traditional | Hardy Diagnostics | 11/02/2000SE |
| K002664 | Hardydisk Levofloxacin, 5MCGJTN · Traditional | Hardy Diagnostics | 10/26/2000SE |
| K002661 | Hardydisk Cefotetan, 30MCGJTN · Traditional | Hardy Diagnostics | 10/26/2000SE |
| K002660 | Hardydisk Lomefloxacin, 10MCGJTN · Traditional | Hardy Diagnostics | 10/26/2000SE |
| K002369 | Hardydisk Gentamicin, 120MCGJTN · Traditional | Hardy Diagnostics | 10/26/2000SE |
| K002367 | Hardy Disk Ceftizoxime, 30MCGJTN · Traditional | Hardy Diagnostics | 10/26/2000SE |
| K002656 | Hardydisk Cefuroxime, 30MCGJTN · Traditional | Hardy Diagnostics | 10/25/2000SE |
| K002368 | Hardydisk Streptomycin, 300MCGJTN · Traditional | Hardy Diagnostics | 10/25/2000SE |
| K002663 | Hardydisk Netilmicin, 30MCGJTN · Traditional | Hardy Diagnostics | 10/19/2000SE |
| K002165 | Linezolid, 30UG, BBL Sensi-DiscJTN · Traditional | Dickinson, and Co. | 09/05/2000SE |
| K001728 | Hardy Disk Clarithromycin, 15MCGJTN · Traditional | Hardy Diagnostics | 07/27/2000SE |
| K001487 | Hardydisk Cinoxacin, 100 MCGJTN · Traditional | Hardy Diagnostics | 06/07/2000SE |
| K001490 | Hardydisk Cefonicid, 30 MCGJTN · Traditional | Hardy Diagnostics | 06/01/2000SE |
| K001489 | Hardydisk Cefoperazone, 75 MCGJTN · Traditional | Hardy Diagnostics | 06/01/2000SE |
| K000930 | Gatifloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 05/22/2000SE |
| K000928 | Quinupristin/Dalfopristin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 05/15/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/13/2000SE |
| K000526 | Hardydisk, Cephalothin 30MCGJTN · Traditional | Hardy Diagnostics | 04/13/2000SE |
| K000525 | Hardydisk Ofloxacin 5MCGJTN · Traditional | Hardy Diagnostics | 04/07/2000SE |
| K000524 | Hardydisk, Cefotaxime 30MCGJTN · Traditional | Hardy Diagnostics | 04/07/2000SE |
| K000509 | Hardydisk, Vancomycin 30MCGJTN · Traditional | Hardy Diagnostics | 04/07/2000SE |
| K000440 | Hardydisk Ceftriaxone 30MCGJTN · Traditional | Hardy Diagnostics | 04/07/2000SE |
| K000272 | Hardydisk, NitrofurantoinJTN · Traditional | Hardy Diagnostics | 04/07/2000SE |
| K000271 | Hardydisk, Sulfa/TrimethJTN · Traditional | Hardy Diagnostics | 04/07/2000SE |
| K000268 | Hardydisk, Ampicillin, 10MCGJTN · Traditional | Hardy Diagnostics | 04/07/2000SE |
| K000261 | Hardydisk, Piperacillin/Tazobactam, 110MCGJTN · Traditional | Hardy Diagnostics | 04/07/2000SE |
| K000305 | Hardydisk, Cefoxitin, 30MCGJTN · Traditional | Hardy Diagnostics | 03/31/2000SE |
| K000304 | Hardydisk, Tetracycline 30MCGJTN · Traditional | Hardy Diagnostics | 03/29/2000SE |
| K000302 | Hardy Disk, Penicillin, 10 UnitsJTN · Traditional | Hardy Diagnostics | 03/24/2000SE |
| K000259 | Hardydisk, Ceftazidime, 30MCGJTN · Traditional | Hardy Diagnostics | 03/21/2000SE |
| K000258 | Hardydisk, Ciprofloxacin, 5MCGJTN · Traditional | Hardy Diagnostics | 03/21/2000SE |
| K000203 | Hardydisk, Kanamycin, 30MCGJTN · Traditional | Hardy Diagnostics | 03/21/2000SE |
| K000181 | Hardydisk, Carbenicillin, 100MCGJTN · Traditional | Hardy Diagnostics | 03/02/2000SE |
| K000175 | Hardydisk Ticarillin 75MCGJTN · Traditional | Hardy Diagnostics | 03/02/2000SE |
| K000201 | Hardydisk, Streptomycin 10MCGJTN · Traditional | Hardy Diagnostics | 02/29/2000SE |
| K000182 | Hardydisk Tobramycin, 10MCGJTN · Traditional | Hardy Diagnostics | 02/29/2000SE |
| K000130 | Hardydisk, Nalidixic Acid, 30MCGJTN · Traditional | Hardy Diagnostics | 02/29/2000SE |
| K000183 | Hardydisk, Piperacillin, 100MCGJTN · Traditional | Hardy Diagnostics | 02/28/2000SE |
| K000128 | Hardydisk, Cefazolin, 30MCGJTN · Traditional | Hardy Diagnostics | 02/18/2000SE |
| K994134 | Hardydisk Oxacillin, 1MCGJTN · Traditional | Hardy Diagnostics | 02/17/2000SE |
| K000022 | Hardydisk Cefamandole, 30MCGJTN · Traditional | Hardy Diagnostics | 02/17/2000SE |
| K994150 | Hardydisk Norfloxacin, 10MCGJTN · Traditional | Hardy Diagnostics | 02/16/2000SE |
| K994135 | Hardydisk Erythromycin, 15MCGJTN · Traditional | Hardy Diagnostics | 02/16/2000SE |
| K994212 | Hardydisk Mezlocillin 75MCGJTN · Traditional | Hardy Diagnostics | 02/15/2000SE |
| K994129 | Hardydisk Cefixime, 5MCGJTN · Traditional | Hardy Diagnostics | 02/11/2000SE |
| K994091 | Hardydisk Gentamicin, 10MCGJTN · Traditional | Hardy Diagnostics | 02/11/2000SE |
| K994089 | Hardydisk Chloramphenicol, 30MCGJTN · Traditional | Hardy Diagnostics | 02/11/2000SE |
| K994046 | Hardydisk Cefaclor 30MCGJTN · Traditional | Hardy Diagnostics | 02/01/2000SE |
| K994132 | Hardydisk Imipenem, 10MCGJTN · Traditional | Hardy Diagnostics | 01/18/2000SE |
| K994067 | Hardy Disk Ampicillin/SulbactamJTN · Traditional | Hardy Diagnostics | 01/14/2000SE |
| K994063 | Hardydisk Aztreonam, 30MCGJTN · Traditional | Hardy Diagnostics | 01/14/2000SE |
| K994051 | Hardydisk Doxycycline, 30MCGJTN · Traditional | Hardy Diagnostics | 01/10/2000SE |
| K993993 | Hardydisk Amikacin 30MCGJTN · Traditional | Hardy Diagnostics | 12/27/1999SE |
| K993994 | Hardydisk Azithromycin 15MCGJTN · Traditional | Hardy Diagnostics | 12/21/1999SE |
| K993577 | Cefotaxime/Clavulanic, 30/10UG, BBL Sensi-Disc and Ceftazidime/Clavulanic Acid, 30/10UG…JTN · Traditional | Becton Dickinson Microbiology Systems | 12/01/1999SE |
| K992853 | Pasco Mic and Mic/Id Panels, CefdinirJTN · Traditional | Pasco Laboratories, Inc. | 11/04/1999SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/03/1999SE |
| K992726 | Pasco Mic and Mic/Id Panels, Quinupristin/Dalfopristin for Nonfastidious OrganismsJTN · Traditional | Pasco Laboratories, Inc. | 11/03/1999SE |
| K992717 | Pasco Mic and Mic/Id Panels,Quinupristin/DalfopristinJTN · Traditional | Pasco Laboratories, Inc. | 11/02/1999SE |
| K992647 | Pasco Mic and Mic/Id Panels, ErythromycinJTN · Traditional | Pasco Laboratories, Inc. | 10/19/1999SE |
| K992646 | Pasco Mic and Mic/Id Panels, PenicillinJTN · Traditional | Pasco Laboratories, Inc. | 10/19/1999SE |
| K992593 | Pasco Mic and Mic/Id Panels, ChloramphenicolJTN · Traditional | Pasco Laboratories, Inc. | 10/14/1999SE |
| K992568 | Pasco Mic and Mic/Id Panels, CefotaximeJTN · Traditional | Pasco Laboratories, Inc. | 10/14/1999SE |
| K992562 | Pasco Mic and Mic/Id Panels, CeftriaxoneJTN · Traditional | Pasco Laboratories, Inc. | 10/13/1999SE |
| K992546 | Pasco Mic and Mic/Id Panels, MeropenemJTN · Traditional | Pasco Laboratories, Inc. | 10/12/1999SE |
| K992507 | Pasco Mic and Mic/Id Panels, TrovafloxacinJTN · Traditional | Pasco Laboratories, Inc. | 10/08/1999SE |
| K992420 | Modification of Pasco Mic and Mic/Id PanelsJTN · Traditional | Pasco Laboratories, Inc. | 09/27/1999SE |
| K992297 | Pasco Mic and Mic/Id Panels, LevofloxacinJTN · Traditional | Pasco Laboratories, Inc. | 09/03/1999SE |
| K992077 | Pasco Mic and Mic/Id Panels (Ofloxacin)JTN · Traditional | Pasco Laboratories, Inc. | 09/03/1999SE |
| K992076 | Pasco Mic and Mic/Id Panels (Cefuroxime)JTN · Traditional | Pasco Laboratories, Inc. | 08/30/1999SE |
| K984513 | Trovafloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 04/02/1999SE |
| K984608 | Gentamicin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 03/09/1999SE |
| K984036 | Netilmicin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 01/13/1999SE |
| K983718 | Meropenem Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 12/11/1998SE |
| K982669 | Oxoid Streptomycin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 09/09/1998SE |
| K982528 | Nafcillin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 09/09/1998SE |
| K982526 | Sparfloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 09/09/1998SE |
| K982524 | Amoxicillin/Clavulanic Acid Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 09/09/1998SE |
| K982523 | Sulfisoxazole Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 09/09/1998SE |
| K982520 | Cefonicid Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 09/09/1998SE |
| K982519 | Levofloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 09/09/1998SE |
| K982517 | Cefprozil Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 09/09/1998SE |
| K982235 | Pasco Mic and Mic/Id PanelsJTN · Traditional | Pasco Laboratories, Inc. | 07/30/1998SE |
| K981517 | Cefdinir, 5 Ug, Sensi-DiscJTN · Traditional | Becton Dickinson Microbiology Systems | 06/09/1998SE |
| K980955 | Pasco Mic and Mic/Id PanelsJTN · Traditional | Pasco Laboratories, Inc. | 05/18/1998SE |
| K980683 | Trovafloxacin 10G, Sensi-DiscJTN · Traditional | Becton Dickinson Microbiology Systems | 05/01/1998SE |
| K974578 | Grepafloxacin, 5 MG, Sensi-DiscJTN · Traditional | Becton Dickinson Microbiology Systems | 02/23/1998SE |
| K971636 | Rifampicin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 01/28/1998SE |
| K974394 | Enoxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 01/14/1998SE |
| K971637 | Compound Sulphonamides Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 12/23/1997SE |
| K973479 | Cefmetazole Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 12/01/1997SE |
| K973489 | Loracarbef Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 10/10/1997SE |
| K973488 | Lomefloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 10/10/1997SE |
| K973487 | Cefpodoxime Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 10/06/1997SE |
| K971638 | Clarithromycin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 08/20/1997SE |
| K971632 | Ticarcillin/Clavulanic Acid Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 08/13/1997SE |
| K972098 | Fosfomycin, 200 MG, Sensi-DiscJTN · Traditional | Becton Dickinson Microbiology Systems | 07/28/1997SE |
| K971635 | Azithromycin Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 07/03/1997SE |
| K971633 | Piperacillin/Tazobactam Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 07/03/1997SE |
| K971631 | Cefotetan Antimicrobial Susceptibility Test DiscJTN · Traditional | Oxoid , Ltd. | 07/03/1997SE |
| K971211 | Dispens-O-Disc SparfloxacinJTN · Traditional | Difco Laboratories, Inc. | 04/14/1997SE |
| K971120 | Dispens-O-Disc (TM) LevofloxacinJTN · Traditional | Difco Laboratories, Inc. | 04/14/1997SE |
| K970831 | Remel Sparfloxacin 5G Susceptibilty DiskJTN · Traditional | Remel, Inc. | 04/02/1997SE |
| K970830 | Remel Levofloxacin 5G Susceptibilty DiskJTN · Traditional | Remel, Inc. | 04/02/1997SE |
| K970385 | Sparflozacin, 5 MCG, Sensi-DiscJTN · Traditional | Becton Dickinson Microbiology Systems | 03/10/1997SE |
| K970212 | Levofloxacin, 5MCG, Sensi-DiscJTN · Traditional | Becton Dickinson Microbiology Systems | 03/06/1997SE |
| K964495 | Cefepine Antimicrobial Susceptibility Test DiscJTN · Traditional | Unipath , Ltd. | 02/07/1997SE |
| K964492 | Ciprofloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Unipath , Ltd. | 02/07/1997SE |
| K964491 | Norfloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Unipath , Ltd. | 02/07/1997SE |
| K964490 | Aztreonam Antimicrobial Susceptibility Test DiscJTN · Traditional | Unipath , Ltd. | 02/07/1997SE |
| K964489 | Cefaclor Antimicrobial Susceptibility Test DiscJTN · Traditional | Unipath , Ltd. | 02/07/1997SE |
| K964487 | Imipenem Antimicrobial Susceptibility Test DiscJTN · Traditional | Unipath , Ltd. | 02/07/1997SE |
| K964512 | Ceftizoxime Antimicrobial Susceptibility Test DiscJTN · Traditional | Unipath , Ltd. | 02/06/1997SE |
| K964501 | Sulbactam/Ampicillin Antimicrobial Susceptibility Test DiscJTN · Traditional | Unipath , Ltd. | 02/06/1997SE |
| K964496 | Cefixime Antimicrobial Susceptibilty Test DiscJTN · Traditional | Unipath , Ltd. | 02/06/1997SE |
| K964493 | Ofloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | Unipath , Ltd. | 02/06/1997SE |
| K965159 | Cetibuten, 30MCG, Sensi-DiscJTN · Traditional | Becton Dickinson Microbiology Systems | 02/04/1997SE |
| K964421 | Remel Meropenem 10UG Susceptibility DiskJTN · Traditional | Remel, L.P. | 12/06/1996SE |
| K963845 | Meropenem, 10 MCG, Sensi-DiscJTN · Traditional | Becton Dickinson Microbiology Systems | 10/25/1996SE |
| K963508 | Dispens-O-Disc MeropenemJTN · Traditional | Difco Laboratories, Inc. | 09/26/1996SE |
| K961819 | Streptomycin Disk (300MCG)JTN · Traditional | Remel, L.P. | 07/10/1996SE |
| K961818 | Gentamicin Disk (120MCG)JTN · Traditional | Remel, L.P. | 07/10/1996SE |
| K961188 | Cefepime, 30 MCG, Sensi-DiscJTN · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/05/1996SE |
| K955669 | Remel Cefepime 30 Ug Susceptibility DiskJTN · Traditional | Remel Co. | 02/23/1996SE |
| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | Difco Laboratories, Inc. | 12/19/1994SE |
| K943407 | Gentamicin 120 Ug, Streptomycin 30 Ug Sensi-Disc Suspectibility TestsJTN · Traditional | Becton Dickinson Microbiology Systems | 10/27/1994SE |
| K935975 | Remel Piperacillin/Tazobactam 100/10 MCGJTN · Traditional | Remel, Inc. | 09/19/1994SE |
| K940359 | Piperacillin/Tozobactam, 100/10 MCG Sensi-DiscJTN · Traditional | Becton Dickinson Microbiology Systems | 03/01/1994SE |
| K930702 | Dryslide CefinJTN · Traditional | Difco Laboratories, Inc. | 12/22/1993SE |
| K934100 | Remel Cefprozil 30 MCG Susceptibility DiskJTN · Traditional | Remel Co. | 11/22/1993SE |
| K933657 | Remel Azithromlycin 15 MCG Susceptibility DiskJTN · Traditional | Remel Co. | 10/28/1993SE |
| K933118 | Remel Clarithromycin 15 MCG Susceptibility DiskJTN · Traditional | Remel Co. | 08/10/1993SE |
| K932052 | Adams Scientific Sensitivity DiscsJTN · Traditional | Adams Scientific, Inc. | 07/19/1993SE |
| K931799 | Remel Loracarbef 30 MCG Susceptibility DiskJTN · Traditional | Remel Co. | 06/15/1993SE |
| K931289 | Remel Cefpodoxime 10 MCG Susceptibility DiskJTN · Traditional | Remel Co. | 06/02/1993SE |
| K931290 | Remel Cefmetazole 30 MCG Susceptibility DiskJTN · Traditional | Remel Co. | 05/20/1993SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2887-2026 Class II | HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30)…Due to incorrect cartridges include in affected products that there is the potential for false-susceptible… | Hardy Diagnostics | 06/08/2026Open, Classified |
| Z-1075-2025 Class II | Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial… | Oxoid Limited | 12/23/2024Open, Classified |
| Z-0621-2025 Class II | BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g…BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to… | Becton Dickinson & Co. | 11/06/2024Open, Classified |
| Z-1040-2024 Class II | BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1039-2024 Class II | BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1038-2024 Class II | BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1037-2024 Class II | BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1036-2024 Class II | BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1035-2024 Class II | BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1034-2024 Class II | BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1033-2024 Class II | BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1032-2024 Class II | BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1031-2024 Class II | BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1030-2024 Class II | BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1029-2024 Class II | BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1028-2024 Class II | BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1027-2024 Class II | BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1026-2024 Class II | BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1025-2024 Class II | BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1024-2024 Class II | BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1023-2024 Class II | BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1022-2024 Class II | BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1021-2024 Class II | BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1020-2024 Class II | BD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1019-2024 Class II | BD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1018-2024 Class II | BD BBL Sensi Disc Cefepime - 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1017-2024 Class II | BD BBL Sensi Disc Cefaclor - 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1016-2024 Class II | BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1015-2024 Class II | BD BBL Sensi Disc Azithromycin -15 g, Catalog Number 231682used for semi-quantitative in…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1014-2024 Class II | BD BBL Sensi Disc Augmentin - 3g, Catalog Number 291270used for semi-quantitative in…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1013-2024 Class II | BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 g, Catalog Number 231660. Used for…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1012-2024 Class II | BD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No.…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-1011-2024 Class II | Sensi Disc Amoxicillin with Clavulanic Acid 20/10 g, Catalog No. 231628 and 231629.…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | Becton Dickinson & Co. | 01/08/2024Open, Classified |
| Z-2142-2021 Class II | ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United…Out of Specification | Remel Inc | 06/18/2021Terminated |
| Z-0443-2016 Class II | Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged…Antibiotic concentration may be insufficient which may result in incorrect test results. | Remel Inc | 11/06/2015Terminated |
| Z-1246-2014 Class II | Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The…Some of the discs may not be impregnated with the antibiotic. | Remel Inc | 02/18/2014Terminated |
| Z-0734-2014 Class II | Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem…Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than… | Remel Inc | 11/21/2013Terminated |
| Z-0795-2014 Class II | Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in…Cartridges may contain individual discs which were not impregnated with antibiotic. | Remel Inc | 04/09/2013Terminated |
| Z-0794-2014 Class II | Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in…Cartridges may contain individual discs which were not impregnated with antibiotic. | Remel Inc | 04/09/2013Terminated |
| Z-0793-2014 Class II | Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in…Cartridges may contain individual discs which were not impregnated with antibiotic. | Remel Inc | 04/09/2013Terminated |
| Z-0792-2014 Class II | Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in…Cartridges may contain individual discs which were not impregnated with antibiotic. | Remel Inc | 04/09/2013Terminated |
| Z-2081-2013 Class III | Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B…Use of affected lots may give false indication of susceptibility to Nitrofurantoin. | Remel Inc | 03/25/2013Terminated |
| Z-0528-2014 Class III | Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs…Boxes labeled as CIP5 may contain cartridges of AMP5. | Remel Inc | 11/21/2012Terminated |
| Z-0808-2013 Class II | Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50…The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of… | Remel Inc | 08/21/2012Terminated |
| Z-0790-2013 Class II | Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid…The firm is recalling the product due to some cartridges may contain individual discs that are not… | Remel Inc | 08/21/2012Terminated |
| Z-0669-2007 | BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10…Antibiotic susceptibility testing reagent was not manufactured according to specifications and may cause… | Becton Dickinson & Co. | 02/19/2007Terminated |