Recall Z-0086-2018— BioMerieux SA
Class II · Terminated
Class II FDA medical device recall by BioMerieux SA, initiated 2017-10-18, terminated 2021-08-24. FDA's recall record names no specific 510(k) clearance for this event. Product: NucliSENS Lysis Buffer Extended lot for RES 76675. 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..
- Recalling firm
- BioMerieux SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-18
- Terminated
- 2021-08-24
- Firm location
- Marcy L'Etoile, N/A, France
Product description
NucliSENS Lysis Buffer Extended lot for RES 76675
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.