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U.S. Department of Health and Human Services

Class 2 Device Recall NucliSENS Lysis Buffer

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 Class 2 Device Recall NucliSENS Lysis Buffersee related information
Date Initiated by FirmOctober 18, 2017
Create DateNovember 09, 2017
Recall Status1 Terminated 3 on August 24, 2021
Recall NumberZ-0086-2018
Recall Event ID 78387
Product Classification General purpose reagent - Product Code PPM
ProductNucliSENS Lysis Buffer Extended lot for RES 76675
Code Information REF 200292, Lot 17022802, Exp Date 01/28/2019  Extended lot for RES 76675
Recalling Firm/
Manufacturer		 BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionUS 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 in Commerce911 units
DistributionDistributed domestically to MD, CO, and OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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