Beckman Coulter — Class II medical device recall Z-1023-2015
Terminated recall by Beckman Coulter Inc., reported 2015-02-04, distributed nationwide. N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen ov
| Recall number | Z-1023-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2014-12-15 |
| Classified | 2015-01-28 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2016-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, GR, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KE, KR, KW, LB, LK, LT, MA, MX, MY, NG, NL, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Model numbers | OSR6X30 |
Product
Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
Reason for recall
N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.
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-1023-2015. 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.