Recall Z-1583-2023 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
| Date | May 12, 2023 (initiated Mar 31, 2023) |
| Status | Completed |
| Reason | Some of the tubes may be incorrectly labeled. |
| Root cause | Labeling Change Control |
| Action | The recalling firm issued a letter dated 3/30/2023 on 3/31/2023 via email to their sole customer. The letter provided the reason for recall, contained detailed information regarding the complaint, provided photographs of the product which included incorrect tube labels and correct tube labels, investigation results, health risk analysis, and actions to be taken. Those actions included to discontinue use of the product immediately and isolate it, assess the risks and consequences of the use of the defective product in accordance with the customer's procedures and take appropriate action, and |
| Quantity | 36,000 pieces (30 full cases) |
| Distribution | US Nationwide distribution in the states of WI and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960860 | GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 Greiner America, Inc., Sep 5, 1996 |