Recall Z-0122-2015— Siemens Healthcare Diagnostics

Name: FDA recall Z-0122-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-19

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2014-09-19, terminated 2015-11-18. It names one FDA 510(k) clearance: K931409. 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: 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..

Recalling firm: Siemens Healthcare Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2014-09-19
Terminated: 2015-11-18
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K931409 — IMMULITE CORTISOLDiagnostic Products Corp.·cleared 1993-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.