Recall Z-0733-2024 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
| Date | Jan 16, 2024 (initiated Dec 12, 2023) |
| Status | Open, Classified |
| Reason | Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment. |
| Root cause | Software design |
| Action | Distributors were emailed the notification letter dated 12/11/2023 on 12/12/2023 and the other consignees were sent the letter on 12/13-14/2023 via email or USPS. The distributor letter explained the issue, identified the product, the potential health hazard, informed the consignee they should not use the tubes, and requests use of the product immediately be stopped and the product be isolated in their facility. The consignee should assess the risks and consequences of the use of the defective product in accordance with their procedures and take appropriate action. The enclosed Product Disp |
| Quantity | 495,600 tubes |
| Distribution | US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971239 | GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc., May 12, 1997 |