Z-0122-2015Class II

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

Name: Z-0122-2015 IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro...
Creator: Siemens Healthcare Diagnostics
Published: 2014-09-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-09-19 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics began a recall of IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers... on 2014-09-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0122-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-19
Posted: 2014-10-23
Terminated: 2015-11-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CGR Radioimmunoassay, Cortisol
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: US: 772 units, Canada: 43 units
Distribution: Worldwide Distribution: US (nationwide) and internationally to Canada.
Product codes and lots: Lots: 381 (exp. 10/31/2014), 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0122-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0122-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-23

Product code CGR

K931409Class IIImmulite CortisolDiagnostic Products Corp. / cleared 1993-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)