FDA Device recall Z-0613-2013
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805
- FDA Device
- Class II
- terminated
- Published 2013-01-02
On 2013-01-02 the FDA classified a Class II recall of Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805 by Beckman Coulter, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0613-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-07-27 |
| Published | 2013-01-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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
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.
Identifiers
| code_info | 019818, 021654, 024072 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0613-2013%22
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