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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88658

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

Open FDA event record

Event summary

Timeline bucket
September 02, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BioMerieux SA

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

MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

Z-0084-2022
Recall number
Z-0084-2022
Initiated
September 02, 2021
Classification
Class II
Status
Terminated
Recalling firm
BioMerieux SA
Quantity
542 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, there is a risk for a false negative result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, there is a risk for a false negative result.

Code information

MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Austria, Australia, Belgium, Canada, Switzerland, Chile, Columbia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong, Canary Islands, Ireland, India, Italy, Japan, South Korea, The Netherlands, Norway, Poland, Portugal, Sweden, Singapore, South Africa.