Home / Recalls / BIOMERIEUX - Grenoble / Z-1365-2020

Z-1365-2020 Class II Terminated

Recalled by BIOMERIEUX - Grenoble — Grenoble Cedex 1, N/A

Recall Details

Product Type: Devices
Report Date: March 4, 2020
Initiation Date: January 10, 2020
Termination Date: April 14, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1024

Product Description

NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.

Reason for Recall

Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. 200292, lot 19040201. The issue is linked to drift of pH electrode dysfunction.

Distribution Pattern

No US distribution. No Mexican consignees. International distribution to South Africa, Uruguay, Tanzania, Romania, Netherlands, Macao, Italy, India, Hong Kong, United Kingdom, France, Spain, Germany, China, Chile, Canada, Belgium, Australia, Argentina, Curacao.

Code Information

Lot 19040201, Expiry 28-Feb-2021