Tubes, Vacuum Sample, With Anticoagulant
FDA product code GIM · Class II (moderate risk) · 21 CFR 862.1675 · Clinical Chemistry
39510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Sherwood Medical Industries 5
- Becton, Dickinson and Company 3
- Jelco Laboratories 3
- Bd Becton Dickinson Vacutainer Systems Preanalytic 3
- Sherwood Medical Co. 3
- Mbo Laboratories, Inc. 2
- Becton Dickinson Vacutainer Systems 2
- Organon, Inc. 2
- Kimble-Terumo, Inc. 1
- The University of Chicago 1
- Exel Intl. 1
- Terumo Medical Corp. 1
- Radiometer America, Inc. 1
- Transidyne General Corp. 1
- Abbott Laboratories 1
- Fichte, Graves, and Hunt 1
- Clasrock 1
- International Technidyne Corp. 1
- Cambridge Multi-Draw, Inc. 1
- Organon Teknika Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240455 | BD Vacutainer® Citrate Blood Collection TubesGIM · Traditional | Becton, Dickinson and Company | 10/31/2024SE |
| K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood…GIM · Traditional | Becton, Dickinson and Company | 11/27/2023SE |
| K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesGIM · Traditional | Becton, Dickinson and Company | 08/25/2023SE |
| K162723 | TransFix/EDTA Vacuum Blood Collection TubesGIM · Traditional | Caltag Medsystems, Ltd. | 06/22/2017SE |
| K080552 | Cyto-Chex BCTGIM · Traditional | Streck | 07/31/2008SE |
| K012152 | DS30 Hcy Blood Collection TubesGIM · Traditional | Drew Scientific , Ltd. | 09/18/2001SE |
| K971449 | Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple)GIM · Traditional | Becton Dickinson Vacutainer Systems | 06/17/1997SE |
| K971221 | Greiner Vacuette Blood Collection TubeGIM · Traditional | Greiner America, Inc. | 05/02/1997SE |
| K951886 | Lok-On Needle Disposal SystemGIM · Traditional | Becton Dickinson Vacutainer Systems | 06/30/1995SE |
| K945458 | Vacutainer Brand Safety-Gard Phlebotomy SystemGIM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/06/1995SE |
| K944814 | Corvac Plastic Blood Collection TubeGIM · Traditional | Sherwood Medical Co. | 12/19/1994SE |
| K940058 | Monoject Blood Collection Tubes W/Safety StopperGIM · Traditional | Sherwood Medical Co. | 05/02/1994SE |
| K933939 | Bact/Alert Blood Collection Adapter Cap and InsertGIM · Traditional | Organon Teknika Corp. | 02/07/1994SE |
| K933386 | Vacutainer Brand Safety-Gard Needle Holder & Needle Disposable Container SystemGIM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/12/1993SE |
| K922858 | Multidraw SystemGIM · Traditional | Cambridge Multi-Draw, Inc. | 11/16/1992SESK |
| K922468 | Angel Wing Sets -- ModifiedGIM · Traditional | Mbo Laboratories, Inc. | 07/10/1992SE |
| K921778 | Directdraw SuperserumGIM · Traditional | International Technidyne Corp. | 05/28/1992SE |
| K921636 | Vacutainer(R) Brand Safety-Lok Blood Collect SetGIM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/29/1992SE |
| K920184 | Angel Wing Safety Blood Collection with Tube Hold.GIM · Traditional | Mbo Laboratories, Inc. | 02/18/1992SE |
| K915213 | Corvac Blood Collection TubeGIM · Traditional | Sherwood Medical Co. | 01/08/1992SE |
| K914901 | Vacutainer KitGIM · Traditional | Abbott Laboratories | 01/08/1992SE |
| K896373 | 1400 Series Evidence Collection KitGIM · Traditional | Transidyne General Corp. | 02/26/1990SE |
| K896514 | QS90 Smooth E Arterial Blood SamplerGIM · Traditional | Radiometer America, Inc. | 01/23/1990SE |
| K882501 | Accufibrin(Tm) Blood Collection System AF100GIM · Traditional | Terumo Medical Corp. | 07/18/1988SE |
| K861449 | Vacuum Blood Collecting System (Neo-Tube)GIM · Traditional | Exel Intl. | 09/16/1986SE |
| K803182 | Syringe for Blood SamplingGIM · Traditional | The University of Chicago | 01/16/1981SE |
| K801015 | Prezapak L Arterial Blood Sampling KitGIM · Traditional | Kimble-Terumo, Inc. | 05/14/1980SE |
| K791200 | Pre-DentGIM · Traditional | Fichte, Graves, and Hunt | 08/10/1979SE |
| K771874 | J-Vac Vacuum TubeGIM · Traditional | Jelco Laboratories | 12/02/1977SE |
| K771985 | Filter Sampler Blood Serum FilterGIM · Traditional | Clasrock | 11/02/1977SE |
| K771305 | Liquaemin Sodium, Heparin Sodium Etc.GIM · Traditional | Organon, Inc. | 08/04/1977SE |
| K771304 | Liquaemib Sodium Preservative, Etc.GIM · Traditional | Organon, Inc. | 08/04/1977SE |
| K771056 | Blood Collection Tube, GreenGIM · Traditional | Sherwood Medical Industries | 06/29/1977SE |
| K771055 | Blood Collection Tube, RedGIM · Traditional | Sherwood Medical Industries | 06/29/1977SE |
| K771054 | Blood Collection Tube, BlueGIM · Traditional | Sherwood Medical Industries | 06/29/1977SE |
| K771053 | Blood Collection Tube, GrayGIM · Traditional | Sherwood Medical Industries | 06/29/1977SE |
| K771052 | Blood Collection Tube, LavenderGIM · Traditional | Sherwood Medical Industries | 06/27/1977SE |
| K760019 | Vacuum Tubes, Pediatric Sizes (J-Vac)GIM · Traditional | Jelco Laboratories | 07/20/1976SE |
| K760018 | Vacuum Tubes, Sterile (J-Vac)GIM · Traditional | Jelco Laboratories | 07/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0408-2026 Class II | Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the… | Greiner Bio-One North America, Inc. | 08/08/2025Open, Classified |
| Z-2507-2021 Class II | Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue…Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. | Greiner Bio-One North America, Inc. | 08/20/2021Terminated |
| Z-1534-2021 Class II | VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white…VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the… | Greiner Bio-One North America, Inc. | 03/29/2021Terminated |
| Z-1714-2020 Class II | VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3%… | Greiner Bio-One North America, Inc. | 03/12/2020Terminated |
| Z-1684-2017 Class II | Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD.…Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were… | Streck | 02/23/2017Open, Classified |
| Z-2154-2012 Class II | 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America…Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for… | Greiner Bio-One North America, Inc. | 07/02/2012Terminated |
| Z-1336-2012 | BacT/ALERT Blood Collection Adapter The BacT/ALERT Adapter Cap is intended for use as an…The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer… | bioMerieux, Inc. | 03/05/2012Terminated |