Device recall
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)
- Recall number
- Z-0200-2027
- Event id
- 99518
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Greiner Bio-One North America, Inc.
- Report date
- Oct 28, 2026
- Posted
- Oct 21, 2026
- Initiated
- Jul 29, 2026
- Center classification date
- Oct 21, 2026
- Product code
- JKA
- Device type
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- 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
- Quantity
- 860450
- Code info
- Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12
- Distribution
- U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K960857
- Location
- Monroe, NC, United States