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

FDA device recall Z-1713-2017 · posted 2017-03-19 · Terminated

Recall details

Recalling firm

BioMerieux SA

Reason for recall

Problem with colored eluates for whole blood extractions

Action taken

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

Status

Terminated

Product code

PPM

Quantity affected

1025

Distribution

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

Date initiated

2017-03-07

Date posted

2017-03-19

Date terminated

2020-08-18

Location

Marcy L'Etoile, France