Immunoradiometric assay — Class III medical device recall Z-0648-2013
Terminated recall by Siemens Healthcare Diagnostics, reported 2013-01-16, distributed in CA, GA, IL, IN, MI, MN, NY, PR. The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values wit
| Recall number | Z-0648-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2012-11-28 |
| Classified | 2013-01-07 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2013-10-28 |
| Distributed | CA, GA, IL, IN, MI, MN, NY, PR |
| Countries outside the US | BO, BR, CA, CL, GT, KR, PH, PY, TW |
| Lot numbers | 742, 743 |
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 for recall
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)
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-0648-2013. 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.