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.
What this means for you
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 clin
- 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.
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