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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92451

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 05, 2023
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

2 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 2

Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

Z-2023-2023
Recall number
Z-2023-2023
Initiated
June 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Luminex Corporation
Quantity
3987 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

Code information

UDI/DI 00840487101568, Lot Numbers: 071322023D, 071822023B, 071822023C, 071922023E, 072022023D, 072622023D, 082422023G, 083022023E, 083122023E, 090622023A, 090822023D, 091322023D, 091422023D, 091422023E, 092022023E, 092122023D, 092722023D, 092822023D, 100422023D, 100722023E, 101422023E, 101822023D, 101822023E, 101922023D, 102022023D, 121322023D, 122722023C, 122722023D, 010323023D, 011323023G, 021323023A, 021323023B, 021523023D, 022123023E, 022323023D, 030123023F, 030223023D, 030223023E, 030623023A, 030823023D, 031623023D

Distribution pattern

Worldwide and US Nationwide Distribution

device · product 2 of 2

VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

Z-2024-2023
Recall number
Z-2024-2023
Initiated
June 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Luminex Corporation
Quantity
114 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

Code information

UDI/DI , Lot Numbers: 071222022D, 100622022D

Distribution pattern

Worldwide and US Nationwide Distribution