IMMULITE /IMMULITE 1000 Systems COR Cortisol — Class II medical device recall Z-0122-2015
Terminated recall by Siemens Healthcare Diagnostics, reported 2014-10-29, distributed nationwide. Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 10
| Recall number | Z-0122-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2014-09-19 |
| Classified | 2014-10-23 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-11-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | potency |
| Lot numbers | 381 |
| Model numbers | 10381388, LKC01 |
| Expiration dates | 2014-10-31, 2014-11-30 |
Product
IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
Reason for recall
Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 . Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.
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-0122-2015. 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.