Reported Nov 15, 2017 · Terminated
NucliSENS Lysis Buffer Extended lot for RES 76675
BioMerieux SA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile, N/A · N/A
Is this the product you have?
- NucliSENS Lysis Buffer Extended lot for RES 76675
- Lot codes and dates
- REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675
- Amount recalled
- 911 units
Where it was sold
Why it was recalled
Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.
This product could cause temporary or reversible health problems — stop using it.
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