Recall Z-3027-2020 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.
| Date | Aug 28, 2020 |
| Status | Terminated |
| Reason | Blood collection tubes experienced an issue with separation and clotting |
| Root cause | Under Investigation by firm |
| Action | Greiner Bio-One North America issued an urgent product recall notification on August 28, 2020. It state the following: 1. Stop distributing the mentioned product (concerned item/lot) immediately and isolate defective products in your facility. 2. Complete the Product Disposition form and fax it to Greiner at 800.726.0052 or email to patech@gbo.com. 3. Greiner will contact you for the return or destruction of the product after receiving the attached Product Disposition Site Confirmation form. Greiner will also use this information to send you replacement stock or issue a credit. 4. Please pr |
| Quantity | 1,008,000 pieces |
| Distribution | US Nationwide distribution including in the states of IL, PA, VA, MO, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081929 | VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR Greiner Bio-One North America, Inc., Dec 16, 2008 |