BIOMERIEUX - Grenoble: Medical Device Recall in 2020 - (Recall #: Z-1365-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 10, 2020

Date Posted: March 4, 2020

Recall Number: Z-1365-2020

Event ID: 84766

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.

Status: Terminated

Product Quantity: 1024

Code Information:

Lot 19040201, Expiry 28-Feb-2021

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.

Voluntary or Mandated:

Voluntary: Firm initiated