FDA Device recall Z-0646-2013
Immunoradiometric assay
- FDA Device
- Class III
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class III recall of Immunoradiometric assay by Siemens Healthcare Diagnostics, citing the recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0646-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-11-28 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | CA, GA, IL, IN, MI, MN, NY, PR |
Product
Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
Reason
The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)
Identifiers
| code_info | Lots 969 and 970 |
|---|
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-0646-2013%22
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