FDAFDA recall Z-0200-2027 · Oct 28, 2026
Greiner Bio-One North America, Inc.: Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 4540 recall
Recall found
Product
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 for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12
- Quantity
- 860450
- Distribution
- U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.
- Recalling firm
- Greiner Bio-One North America, Inc., Monroe, NC
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-29
Source: openFDA enforcement record Z-0200-2027 · search recall number Z-0200-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Nov 3, 2026, 2:31 AM EST. The agency notice is the final word.