BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37… — Class II medical device recall Z-0997-2026
Ongoing recall by Beckman Coulter Ireland, Inc., reported 2025-12-31, distributed nationwide. Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogena
| Recall number | Z-0997-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Ireland, Inc., O'Callaghan'S Mills, N/A, Ireland |
| Recall initiated | 2025-10-14 |
| Classified | 2025-12-23 |
| Reported by FDA | 2025-12-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CN, EC, IE, MX, NL, PA, TW |
| UPC / GTIN / UDI-DI | 15099590010348, 15099590020187, 15099590060206 |
| Lot numbers | 2681, 2682, 2683, 2684, 2685, 2686, 2687, 2688, 2689, 2690, 2693, 2694, 2695, 2696, 2702, 2703, 2704, 2705, 2706, 2707, 2708, 2709, 2710, 2712, 2713, 2714, 2715, 2716, 2726, 2728, 2729, 2730, 2731, 2732, 2733, 2734, 2736, 2737, 2738, 2739 and 2 more |
| Model numbers | OSR6137, OSR6237, OSR6637, OSR6X37 |
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 for recall
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0997-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.