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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89568

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

Open FDA event record

Event summary

Timeline bucket
February 09, 2022
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

VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

Z-0742-2022
Recall number
Z-0742-2022
Initiated
February 09, 2022
Classification
Class II
Status
Terminated
Recalling firm
bioMerieux, Inc.
Quantity
480 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Invalid calibrations (out of range high) while using the product.

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

Invalid calibrations (out of range high) while using the product.

Code information

Lot numbers 1008873260, exp. 01JUN2022.

Distribution pattern

Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.