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BioMerieux SA recalls NucliSENS Lysis Buffer Extended lot for RES 76675
Recalled November 15, 2017 · FDA recall Z-0086-2018 · BioMerieux SA
Hazard
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. · FDA Class II
Units
911 units
Sold at
Distributed domestically to MD, CO, and OH.
Description
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.
Product
NucliSENS Lysis Buffer Extended lot for RES 76675
Manufacturer(s)
BioMerieux SA
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →