Beckman Coulter Access Cortisol Reagent Recalled for Cross-Contamination
Beckman Coulter is recalling Access Cortisol Reagent due to cross-contamination that may cause falsely decreased patient results.
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, and the hazard involves inaccurate test results (falsely decreased) rather than direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
Beckman Coulter Inc. is recalling the Access Cortisol Reagent, Catalog Number 33600, Lot 831755. This product is a paramagnetic particle, chemiluminescent immunoassay used for the quantitative determination of cortisol levels in human serum, plasma, and urine.
The recall was initiated because cross-contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted by being falsely decreased by up to 16%.
The affected product was distributed worldwide, including the United States, Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam. Users of the Access Immunoassay Systems should stop using the affected lot and contact Beckman Coulter for further instructions.
The recalled product
- Product
- The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum…
- Manufacturer
- Beckman Coulter Inc.
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 (1)
- Lot Number 831755.
Distribution
Distributed nationwide across the United States.
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