CLASS II ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report

Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex

Luminex is recalling Verigene Enteric Pathogens Nucleic Acid Test (EP), distributed nationwide in the US. The recall was initiated on 5 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/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

Quantity recalled3987 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2023-2023
FDA event ID: 92451
Recalling firm: Luminex, Northbrook, IL
Classification: Class II
Status: Ongoing
Recall initiated: 5 Jun 2023
FDA classified: 28 Jun 2023
Reported: 5 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Jun 2023	Recall initiated by company
28 Jun 2023	Classified by FDA	+23 days
5 Jul 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide and US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide and US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 92451

This product is part of a recall event; the main page for the event is Verigene Clostridium difficile Nucleic Acid Test recalled by Luminex.

Reported	Class	Recall	Company	Reason	Where
5 Jul 2023	CLASS II	Verigene Clostridium difficile Nucleic Acid Test recalled by Luminex	Luminex	Other Bacterial Contamination	Nationwide

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