Access SARS CoV-2 lgG II Reagent — Class II medical device recall Z-1905-2021
Terminated recall by Beckman Coulter Inc., reported 2021-06-30, distributed in AK, AL, AR, AZ, CA, FL, GA, IA…. SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with
| Recall number | Z-1905-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2021-05-07 |
| Classified | 2021-06-21 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2023-03-27 |
| Distributed | AK, AL, AR, AZ, CA, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NY, OH, OK, PA, PR, TN, TX, VA, WI, WV, WY |
| Countries outside the US | AE, AT, CZ, DE, ES, FR, GR, HK, HR, HU, IL, IT, JO, JP, PL, PT, SI, SK |
| Quantity | 13,337 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15099590742744 |
| Model numbers | C69057 |
Product
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Reason for recall
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.
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-1905-2021. 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.