Recall Z-0086-2018 ยท PPM General Purpose Reagent
BioMerieux SA
NucliSENS Lysis Buffer Extended lot for RES 76675
| Date | Oct 18, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | US customers were notified on 10/18/2017 via letter using 2-day Fed Ex shipment. Instructions included notifying all appropriate personnel in the laboratory or to customers if product was further distributed, refrain from using the affected product, and arrange for replacement of affected product by completing and returning the response form. It also instructed customers to contact and discuss any concerns regarding previously reported results with the appropriate Laboratory Medical Director to determine an appropriate course of action. |
| Quantity | 911 units |
| Distribution | Distributed domestically to MD, CO, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.