medical Class II Updated 2020-03-04

BIOMERIEUX - Grenoble recalls NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manuf

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: 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.

Lot/Code Info: Lot 19040201, Expiry 28-Feb-2021

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