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Recall Observatory FDA recall evidence

Device product

NucliSENS Lysis Buffer Extended lot for RES 76675

Z-0086-2018

October 18, 2017

Class II

Product summary

Firm
BioMerieux SA
Event
Event 78387
Status
Terminated
Classification
Class II
Quantity
911 units
Official record key
device-enforcement:Z-0086-2018

Official wording

Reason: 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.

Code information: REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675

Distribution pattern: Distributed domestically to MD, CO, and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.