Siemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 1000 Cortisol Assay reagents due to confirmed positive bias on controls.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The issue is a confirmed positive bias in the assay controls, which is a performance defect rather than a direct physical hazard like a structural failure or contamination.
Plain-English summary
Siemens Healthcare Diagnostics is recalling specific lots of the IMMULITE /IMMULITE 1000 Systems COR Cortisol Assay reagent. The affected product is used for in vitro diagnostic testing to measure cortisol levels in serum. The recall involves Lots 381, 382, and 383, with expiration dates of October 31, 2014, and November 30, 2014.
The recall was initiated after customer complaints reported positive bias on the controls used with the assay. The firm subsequently confirmed that a positive bias exists on these specific lots. A total of 772 units were distributed in the United States and 43 units in Canada.
Healthcare facilities and laboratories should stop using the affected lots immediately. Users should contact Siemens Healthcare Diagnostics for instructions on how to return the product or obtain a replacement.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 381 (exp. 10/31/2014)
- 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014)
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics
See all →- ModerateSiemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results
FDA (Devices) · 2018-03-07
- ModerateSiemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- HighSiemens ADVIA Chemistry A1c_3 Calibrator Recalled for Potential Bias
FDA (Devices) · 2014-09-24
- ModerateSiemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading
FDA (Devices) · 2014-09-24
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSiemens IMMULITE Total IgE Assay Recalled for Positive Bias
FDA (Devices) · 2014-05-07
- HighSiemens Recalls Rubella IgM Assay Kits Due to False Positive Results
FDA (Devices) · 2016-10-19
- HighSiemens Recalls IMMULITE PSA Kits Due to Negative Bias
FDA (Devices) · 2017-02-08
- ModerateSiemens Recalls IMMULITE 2000 Total IgE Assays Due to Positive Bias
FDA (Devices) · 2014-05-07
- HighSiemens Atellica cortisol kits recalled for negative bias in urine testing
FDA (Devices) · 2023-05-10
- ModerateSiemens PSA Assay Kits Recalled for Positive Bias in Results
FDA (Devices) · 2013-09-04