Recall Z-0200-2027 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)
| Date | Oct 21, 2026 (initiated Jul 29, 2026) |
| Status | Open, Classified |
| Reason | Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia. |
| Root cause | Nonconforming Material/Component |
| Action | On 07/29/2026, an "URGENT MEDICAL DEVICE RECALL NOTICE" was emailed to customers informing them that, Greiner Bio-One North America identified a potential ethylenediaminetetraacetic acid (EDTA) contamination issue in a specific lot of VACUETTE Lithium Heparin serum separator tubes. Use of affected tubes may lead to: " Falsely elevated potassium (K+) results " Falsely decreased calcium (Ca++) results Customers are instructed to: " Immediately identify and quarantine all remaining units of item 454008P, lot B26043FM. " Stop using the affected lot for blood collection. " Notify relevant staff (p |
| Quantity | 860450 |
| Distribution | U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR Greiner America, Inc., Aug 30, 1996 |