Recall Z-0818-2020 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.
| Date | Nov 25, 2019 |
| Status | Terminated |
| Reason | The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume. |
| Root cause | Process control |
| Action | The firm initiated the recall by email on 11/25/2019. The letter explained the problem and requested the consignees cease distribution and provide a list of their customers for Greiner to contact. The firm is seeking return or on site destruction of the affected product. |
| Quantity | 1,002,000 tubes |
| Distribution | Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983952 | GREINER VACUETTE BLOOD COLLECTION TUBE Greiner Meditech, Inc., Dec 28, 1998 |