Beckman Coulter — Class II medical device recall Z-2488-2023
Ongoing recall by Beckman Coulter Inc., reported 2023-09-06, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Lipemic interference failed to meet the performance specification listed within the IFU.
| Recall number | Z-2488-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2023-07-12 |
| Classified | 2023-08-30 |
| Reported by FDA | 2023-09-06 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CN, CO, CY, CZ, DE, DK, DZ, EC, EG, ES, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, KR, LB, LT, MA, MX, MY, NL, NZ, OM, PH, PK, PL, PT, QA, RO, RS, SA, SG, SK, TN, TR, TW, UY, VN, ZA |
| Quantity | 12,850 units |
| UPC / GTIN / UDI-DI | 15099590011574 |
| Model numbers | OSR61171 |
Product
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Reason for recall
Lipemic interference failed to meet the performance specification listed within the IFU.
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-2488-2023. 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.