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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)

Class II
Recalling firm
Greiner Bio-One North America, Inc.
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.
Affected products (lot / model / serial)
Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12
Units affected
860450
Distribution pattern
U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.
Firm location
Monroe, NC, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-0200-2027
Recall initiated
July 29, 2026
FDA classification date
October 21, 2026
FDA report date
October 28, 2026
FDA event ID
99518
Last updated on HTM Vibe
November 3, 2026
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