Access Immunoassay Systems Total T4 Calibrators — Class II medical device recall Z-0613-2013
Terminated recall by Beckman Coulter Inc., reported 2013-01-02, distributed nationwide. A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 01981
| Recall number | Z-0613-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2011-07-27 |
| Classified | 2012-12-22 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2012-12-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CR, CZ, DE, EG, ES, FR, GB, GR, ID, IE, IN, IT, JO, JP, LB, MX, MY, NG, NL, PA, PH, PK, RO, RS, SG, SV, TH, TR, TW, VE, VN |
| Model numbers | 33805 |
Product
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
Reason for recall
A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.
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-0613-2013. 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.