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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84766

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 10, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BIOMERIEUX - Grenoble

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-1365-2020
Initiated
January 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
BIOMERIEUX - Grenoble
Quantity
1024

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

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Inspect official wording and provenance

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.

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.