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.
This recall has been terminated (originally issued October 23, 2014).
- Company
- Siemens Healthcare Diagnostics
- Recall Initiated
- September 19, 2014
- Posted
- October 23, 2014
- Terminated
- November 18, 2015
- Recall Number
- Z-0122-2015
- Quantity
- US: 772 units, Canada: 43 units
- Firm Location
- Tarrytown, NY
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution: US (nationwide) and internationally to Canada.
Lot / Code Info
Lots: 381 (exp. 10/31/2014), 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014)
Root Cause
Nonconforming Material/Component
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.