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Recall Observatory FDA recall evidence

Device 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.

Z-0122-2015

September 19, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics
Event
Event 69321
Status
Terminated
Classification
Class II
Quantity
US: 772 units, Canada: 43 units
Official record key
device-enforcement:Z-0122-2015

Official wording

Reason: 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.

Code information: Lots: 381 (exp. 10/31/2014), 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014)

Distribution pattern: Worldwide Distribution: US (nationwide) and internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.