IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use w

FDA device recall Z-0122-2015 · posted 2014-10-23 · Terminated

Recall details

Recalling firm: Siemens Healthcare Diagnostics
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.
Action taken: US Customers were sent an Urgent Medical Device Recall Letter (UMDR2014-09-19, dated 9/19/14) via FedEx on 9/19/14. Outside US Customers were sent an Urgent Field Safety Notice Letter. The letters inform the consignees of the recall of the IMMULITE/IMMULITE 1000 Cortisol (LKCO1) assay, kit lots 381, 382 and 383. Customers were asked to take the following actions: - Please review this letter with your Medical Director. - Discontinue use of and discard the IMMULITE/IMMULITE 1000 Cortisol kit lots listed in the letter. - Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Field Safety Notice letter within thirty (30) days.
Root cause: Nonconforming Material/Component
Status: Terminated
Product code: CGR
Quantity affected: US: 772 units, Canada: 43 units
Distribution: Worldwide Distribution: US (nationwide) and internationally to Canada.
Date initiated: 2014-09-19
Date posted: 2014-10-23
Date terminated: 2015-11-18
Location: Tarrytown, NY

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Related 510(k) clearances

Record	Firm	Date
IMMULITE CORTISOL (K931409)	Diagnostic Products Corp.	1993-05-11