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Terminated

NucliSENS Lysis Buffer Extended lot for RES 76675

FDA Recall Z-0086-2018 · Posted None

Recalling FirmBioMerieux SA
Recall StatusTerminated
Product CodePPM
Date Initiated2017-10-18
Date Terminated2021-08-24
Product Quantity911 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed domestically to MD, CO, and OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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