Access Folate WHO Calibrators — Class II medical device recall Z-0047-2013
Terminated recall by Beckman Coulter Inc., reported 2012-10-17, distributed nationwide. Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results tha
| Recall number | Z-0047-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-07-24 |
| Classified | 2012-10-10 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2013-10-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CN, CO, CZ, DE, EC, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IN, IT, JO, JP, KE, KW, LB, MA, MX, MY, NL, NZ, OM, PA, PH, PK, PL, QA, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, VE, VN, ZA |
| Lot numbers | 122651, 123635, 219962 |
| Model numbers | A98033 |
Product
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Reason for recall
Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
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-0047-2013. 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.