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Terminated

NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens

FDA Recall Z-1713-2017 · Posted 2017-03-19

Recalling FirmBioMerieux SA
Recall StatusTerminated
Product CodePPM
Date Initiated2017-03-07
Date Terminated2020-08-18
Product Quantity1025

Reason for Recall

Problem with colored eluates for whole blood extractions

Firm Action

BioMerieux sent an Urgent Product Safety Correction Notice to all affected customers electronically on March 7, 2017. US customers will be sent a separate letter. The letter requested that they discard the product and notify all customers that use the product. The notification included a reply form to be returned. Customers with questions were instructed to contact their local bioMerieux Customer Service representative. For questions regarding this recall call 314-731-7301.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US including IL, OH, WA, and Internationally to Argentina, Australia, Brazil, Chile, Columbia, France, Hong Kong, Italy, Netherlands, Peru, Spain, Uganda, United Kingdom, and Zimbabwe.

Official Source

View FDA Recall →

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

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