Recall Z-0122-2015 ยท CGR Radioimmunoassay, Cortisol
Siemens Healthcare Diagnostics
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.
| Date | Oct 23, 2014 (initiated Sep 19, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | US: 772 units, Canada: 43 units |
| Distribution | Worldwide Distribution: US (nationwide) and internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931409 | IMMULITE CORTISOL Diagnostic Products Corp., May 11, 1993 |