Exact FDA event identifier

Event 86358

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

Open FDA event record

Event summary

Timeline bucket: December 10, 2018
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 Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

Z-0054-2021

Recall number: Z-0054-2021
Initiated: December 10, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Luminex Corporation
Quantity: 1 system

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

No results/incorrect results due to failure of the hybridization heater.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

No results/incorrect results due to failure of the hybridization heater.

Code information

Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010

Distribution pattern

US distribution in MO. No OUS