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Recall Observatory FDA recall evidence

Device 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.

Z-1365-2020

January 10, 2020

Class II

Product summary

Firm
BIOMERIEUX - Grenoble
Event
Event 84766
Status
Terminated
Classification
Class II
Quantity
1024
Official record key
device-enforcement:Z-1365-2020

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.