BioMerieux NucliSENS Lysis Buffer Recalled for Potential PCR Inhibition
BioMerieux SA is recalling 911 units of NucliSENS Lysis Buffer because residual heme may inhibit PCR reactions, leading to uninterpretable test results.
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. The hazard involves potential test result invalidation due to PCR inhibition, which is a significant quality issue but does not involve direct physical injury or death, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
BioMerieux SA is recalling 911 units of NucliSENS Lysis Buffer (REF 200292, Lot 17022802, Exp Date 01/28/2019). The product was distributed domestically to Maryland, Colorado, and Ohio.
The recall is due to the potential presence of residual heme groups from hemoglobin in whole blood or dried blood spot samples. This residual heme can cause the elute to become colored, which may inhibit PCR reactions. Such inhibition can result in uninterpretable test results or invalidate results if an Internal Control is used.
Users of this product should stop using the affected lots and contact BioMerieux SA for further instructions.
The recalled product
- Product
- NucliSENS Lysis Buffer Extended lot for RES 76675
- Manufacturer
- BioMerieux SA
- Affected units
- 911
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 (3)
- REF 200292
- Lot 17022802
- Exp Date 01/28/2019 Extended lot for RES 76675
Distribution
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