FDA-Device2017-11-15Class II
NucliSENS Lysis Buffer Extended lot for RES 76675
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.
Sold states
Distributed domestically to MD, CO, and OH.
Affected count
911 units
Manufactured in
Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, France
Products
NucliSENS Lysis Buffer Extended lot for RES 76675
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0086-2018Don't want to check this manually?
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