Reported Mar 4, 2020 · Terminated

NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280…

BIOMERIEUX - Grenoble

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BIOMERIEUX - Grenoble · Biomerieux · Grenoble Cedex 1, N/A · N/A

Is this the product you have?

    • NUCLISENS¿ Lysis Buffer
    • IVD
    • REF 200292
    • 48X2 ML LYS Manufacturer bioMerieux SA 376
    • Chemin de l'Orme 69280
  • Marcy-l'Etoile - France - Product Usageto be used for the release of total nucleic acid from biological specimens
Lot codes and dates
    • Lot 19040201
    • Expiry 28-Feb-2021
Amount recalled
1024

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 14, 2022 · Data as of Sep 19, 5:28 PM UTC

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