- 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