FDA Device recall Z-0997-2026
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bica…
- FDA Device
- Class II
- ongoing
- Published 2025-12-31
On 2025-12-31 the FDA classified a Class II recall of BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bica… by Beckman Coulter Ireland, citing bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0997-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-14 |
| Published | 2025-12-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter Ireland |
| Distribution | US |
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.
Identifiers
| code_info | Catalog Numbers / UDI-DI codes: OSR6137 - 15099590020187 Lot Numbers: 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690…Catalog Numbers / UDI-DI codes: OSR6137 - 15099590020187 Lot Numbers: 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2693 2694 2695 2696 OSR6237 - 15099590010348 Lot Numbers: 2702 2703 2704 2705 2706 2707 2708 2709 2710 2712 2713 2714 2715 2716 OSR6637 - 15099590060206 Lot Numbers: 2726 2728 2729 2730 2731 2732 2733 2734 2736 2737 2738 2739 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0997-2026%22
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