Access Folate Calibrators — Class II medical device recall Z-0046-2013
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-0046-2013 |
|---|---|
| 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 | 112788, 115741, 118917 |
| Model numbers | A14207 |
Product
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. 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
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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.