Beckman Coulter Bicarbonate — Class II medical device recall Z-1607-2023
Ongoing recall by Beckman Coulter Inc., reported 2023-05-24, distributed nationwide. There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibrati
| Recall number | Z-1607-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2023-04-05 |
| Classified | 2023-05-18 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, MX, PA, TW |
| Quantity | 48,633 units |
| UPC / GTIN / UDI-DI | 15099590010348 |
| Model numbers | 4X50, OSR6237 |
Product
Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
Reason for recall
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
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-1607-2023. 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.