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Home › FDA recalls › Brand Name: VACUETTE Product Name: LH Lithium Heparin Separ
CLASS II · ModerateFDA

Greiner Bio-One North America, Inc. recalls Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator

📅 Jul 29, 2026 · 📍 Nationwide
Recalling company
Greiner Bio-One North America, Inc.
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
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jul 29, 2026
Reported
Oct 28, 2026
Distribution
U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.
Status
Ongoing
Quantity
860450
Lot / codes
Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12
Company location
Monroe, NC
Recall type
Voluntary: Firm initiated
Recall number
Z-0200-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0200-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.