CLASS II ONGOING Device recall · Reported 13 Jul 2022 · FDA Enforcement Report

Verigene CDF Nucleic Acid Test recalled by Luminex

Luminex is recalling Verigene CDF Nucleic Acid Test, distributed nationwide in the US. The recall was initiated on 17 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946; Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850; Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946.

Quantity recalled296 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-1334-2022
FDA event ID: 90122
Recalling firm: Luminex, Northbrook, IL
Classification: Class II
Status: Ongoing
Recall initiated: 17 Jun 2022
FDA classified: 6 Jul 2022
Reported: 13 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Jun 2022	Recall initiated by company
6 Jul 2022	Classified by FDA	+19 days
13 Jul 2022	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

There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

Product as listed by the FDA

Verigene CDF Nucleic Acid Test, Part No. 30-002-22

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.

Nationwide

Questions about this recall

Why was it recalled?

There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

Which lots are affected?

UDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946; Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850; Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.

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 90122

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

Reported	Class	Recall	Company	Reason	Where
13 Jul 2022	CLASS II	Verigene Enteric Pathogens Nucleic Acid Test recalled by Luminex	Luminex	Other	Nationwide

More recalls from Luminex

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Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Device	CLASS II	Verigene Gram Negative Blood Culture (Bc-gn) Nucleic Acid Test recalled	Luminex	Other	Nationwide
14 Aug 2024Device	CLASS II	Verigene Gram Positive Blood Culture (Bc-gp) Nucleic Acid Test recalled	Luminex	Other Bacterial Contamination	Nationwide
13 Dec 2023Device	CLASS II	Verigene Bc-gp Utility Tray Carrier) recalled by Luminex	Luminex	Device Malfunction	Nationwide
5 Jul 2023Device	CLASS II	Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex	Luminex	Other	Nationwide
5 Jul 2023Device	CLASS II	Verigene Clostridium difficile Nucleic Acid Test recalled by Luminex	Luminex	Other Bacterial Contamination	Nationwide

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