Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog... recall (Greiner Bio-One North America, Inc.)
Medical deviceClass IIOngoing
Summary: Greiner Bio-One North America, Inc. is recalling 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). 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.
What is being recalled
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)
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA. (states named: Colorado, Florida, Illinois, Missouri, Nebraska, New York, Ohio, Pennsylvania, Virginia)
How to tell if yours is affected
Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0200-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 29, 2026 |
| Reported | October 28, 2026 |
| Company | Greiner Bio-One North America, Inc. |
| Company location | Monroe, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 860450 |
More recalls from Greiner Bio-One North America, Inc. · all medical device recalls · recalls from July 2026