IMMULITE Systems Third Generation TSH — Class II medical device recall Z-1885-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2013-08-14, distributed nationwide. A rare variant of TSH, identified in a small cluster of patients, is not detected.
| Recall number | Z-1885-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2013-05-10 |
| Classified | 2013-08-06 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2016-05-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 51,792 |
| Model numbers | 100T, 200T, 500T, 600T, L2KTS2, L2KTS6, LKTS1, LKTS5 |
Product
IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Reason for recall
A rare variant of TSH, identified in a small cluster of patients, is not detected.
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-1885-2013. 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.