AU/DxC AU Magnesium — Class II medical device recall Z-0692-2022
Terminated recall by Beckman Coulter Inc., reported 2022-03-09, distributed in AK, AL, AR, AS, AZ, CA, CO, CT…. Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in th
| Recall number | Z-0692-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2021-12-08 |
| Classified | 2022-02-28 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2025-01-28 |
| Distributed | AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BH, BR, CA, CH, CN, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, GY, HK, HR, HU, ID, IE, IL, IN, IT, JO, KE, KR, KW, LB, LK, LT, MA, MX, MY, NG, NL, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UY, VN, ZA |
| Quantity | 181,776 kits |
| UPC / GTIN / UDI-DI | 15099590010850 |
| Model numbers | OSR6189 |
Product
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Reason for recall
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.
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-0692-2022. 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.