Recall Z-1012-2024
Becton Dickinson & Co. · initiated January 8, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
Codes / lots: Catalog No. 230705 UDI-DI 00382902307051 Lots 1301474 1334111 2025840 2146318 2242344 2276051 2333100 3150355 3234179 ; Catalog No. 231264¿ UDI-DI 30382902312643 Lots 2333100 3030225 3058510 3150355 3234179 3282314 1301474 1334111 2003260 2025840 2146318 2242344 2276051; Catalog No. 231263 UDI-DI 30382902312636 Lots 3010977 3058508 3184064 3234190 1302042 2003517 2146414 2243865 2277199 2339360
Reason for recall
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
FDA-determined cause: Process control
Action taken
On January 8, 2024, the firm notified customers through URGENT Medical Device Product Correction letters. Users were instructed to cease use of catalog number 291270, and to refrain from conducting AST for H. influenzae with impacted Sensi-Discs. Customers should destroy any units of catalog number 291270 in their inventory. Customers should share and post the recall notification within their facility network and forward to any customers to whom they may have distributed the product. Future lots of affected Sensi-Disc products (excluding catalog number 291270) will be labeled with a sticker notifying customers "This product should not be used for the semi-quantitative in vitro susceptibility testing of Haemophilus influenzae." Identify impacted lot numbers: https://legacy.bd.com/alerts-notices/IDS-23-4851.asp For customer questions: Phone: 1-844-823-5433 Say "Recall when prompted Mon-Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
Details
- Recall number
- Z-1012-2024
- Initiated
- January 8, 2024
- Posted by FDA
- February 8, 2024
- Product code
- JTN – Susceptibility Test Discs, Antimicrobial
- Quantity
- 2,363,168 total units
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
- Recalling firm
- Becton Dickinson & Co., Sparks, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 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… | 01/08/2024Open, 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… | 01/08/2024Open, Classified |