Recall Z-0997-2026— Beckman Coulter Ireland, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter Ireland, Inc., initiated 2025-10-14. It names one FDA 510(k) clearance: K131546. Product: BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.. Reason: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample..
- Recalling firm
- Beckman Coulter Ireland, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-14
- Firm location
- O'Callaghan'S Mills, N/A, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
Reason for recall
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Data sourced from openFDA. This site is unofficial and independent of the FDA.