Axis-Shield Homocysteine Reagent Recalled for Performance Deterioration
Axis-Shield Diagnostics is recalling Liquid Stable 2-Part Homocysteine Reagents due to performance deterioration that causes under-recovery of test 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to performance deterioration causing under-recovery, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Axis-Shield Diagnostics, Ltd. is recalling the Liquid Stable (LS) 2-Part Homocysteine Reagent in 100, 200, and 1000 test formats, as well as private label versions distributed by Beckman Coulter. The affected products are intended for the in-vitro quantitative determination of total homocysteine in human plasma or serum on Beckman Coulter AU platforms.
The recall is being issued because of deterioration in the performance of the reagent, which results in under-recovery of the analyte. This performance issue may lead to inaccurate test results.
The recall involves 52 kits and 75 Beckman Coulter brand kits. Distribution was worldwide, including nationwide in the United States (specifically Kentucky, Washington, California, and Pennsylvania) and in Germany. Affected lots include FHBC100/802899574, FHRWR100/802899249, FHRWR1000/802899248, FHRWR200/802899989, FHRWR200/802899250, and FHRWCN1/802900104. Users should stop using the affected reagents and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product…
- Manufacturer
- Axis-Shield Diagnostics, Ltd.
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 (6)
- Part Number/Lot Number: FHBC100/802899574
- FHRWR100/802899249
- FHRWR1000/802899248
- FHRWR200/802899989
- FHRWR200/802899250
- FHRWCN1/802900104
Distribution
Related recalls
Same manufacturer · Axis-Shield Diagnostics, Ltd.
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- HighAxis-Shield Homocysteine Reagent Recalled for Potential Performance Issues
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- ModerateAxis-Shield Homocysteine Reagent Recalled for Potential Performance Issues
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