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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81323

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

Open FDA event record

Event summary

Timeline bucket
October 08, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
bioMerieux, Inc.

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

bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

Z-0443-2019
Recall number
Z-0443-2019
Initiated
October 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
bioMerieux, Inc.
Quantity
268

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some eluates become colored because of remaining hemoglobin in the eluate.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some eluates become colored because of remaining hemoglobin in the eluate.

Code information

Lot Z019EA1LB Exp. 28-MAY-2019.

Distribution pattern

CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh