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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90023

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

Open FDA event record

Event summary

Timeline bucket
April 05, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Luminex Corporation

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

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

Z-1092-2022
Recall number
Z-1092-2022
Initiated
April 05, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Luminex Corporation
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

Code information

Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 21029902 16277059 19233005 11250096 14069051 18255003 *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043 Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006

Distribution pattern

US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None