CLASS II ONGOING Device recall · Reported 22 Sep 2021 · FDA Enforcement Report

Verigene EP Amplification Reagent Kit Test recalled by Luminex

Luminex is recalling Verigene EP Amplification Reagent Kit Test, distributed nationwide in the US. The recall was initiated on 3 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: Verigene Enteric Pathogens (EP) Stool PREP KIT; Catalog Number: 30-002-023; Lots: 111620023A 010421023A, 010621023D, 010721023E, 011121023A, 011221023D, 011821023A, 011921023D, 012521023A, 012821023D, 020921023D, 021021023E, 021721023D 022221023A, 030121023A, 030221023D, 030221023E, 030221023F, 030821023A, 030921023D, 031021023E, 031621023D, 031721023D, 032221023A, 032421023E, 032521023E, 033021023E, 040521023A, 041421023F, 041521023E, 042121023D, 042621023A, 050521023H, 050621023C, 051221023E, 051221023F, 111620023A, 111620023B, 111820023D, 111820023E, 112320023A, 112320023B, 120120023D, 120120023E, 120220023D, 120220023E, 120720023A, 120720023B, 120720023C, 120720023D, 120920023D, 120920023E, 120920023F, 121420023B, 121420023C, 121520023D, 121520023E, 121620023D, 121620023E, 122120023A, 122120023B,, 122220023D, 122220023E, 122820023A, 122820023B, 122920023D, 122920023E, 122920023F

Quantity recalled4579 kits

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-2451-2021
FDA event ID: 88423
Recalling firm: Luminex, Northbrook, IL
Classification: Class II
Status: Ongoing
Recall initiated: 3 Aug 2021
FDA classified: 10 Sep 2021
Reported: 22 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

3 Aug 2021	Recall initiated by company
10 Sep 2021	Classified by FDA	+38 days
22 Sep 2021	Published in enforcement report	+12 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 potential for false positive results.

Product as listed by the FDA

Verigene EP Amplification Reagent Kit Test

Where it was distributed

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

Nationwide

Questions about this recall

Is Verigene EP Amplification Reagent Kit Test recalled?

Yes. Luminex recalled Verigene EP Amplification Reagent Kit Test on 3 Aug 2021. The recall is Class II and its status is Ongoing. Recall number Z-2451-2021.

Why was it recalled?

There is potential for false positive results.

Which lots are affected?

Model: Verigene Enteric Pathogens (EP) Stool PREP KIT; Catalog Number: 30-002-023; Lots: 111620023A 010421023A, 010621023D, 010721023E, 011121023A, 011221023D, 011821023A, 011921023D, 012521023A, 012821023D, 020921023D, 021021023E, 021721023D 022221023A, 030121023A, 030221023D, 030221023E, 030221023F, 030821023A, 030921023D, 031021023E, 031621023D, 031721023D, 032221023A, 032421023E, 032521023E, 033021023E, 040521023A, 041421023F, 041521023E, 042121023D, 042621023A, 050521023H, 050621023C, 051221023E, 051221023F, 111620023A, 111620023B, 111820023D, 111820023E, 112320023A, 112320023B, 120120023D, 120120023E, 120220023D, 120220023E, 120720023A, 120720023B, 120720023C, 120720023D, 120920023D, 120920023E, 120920023F, 121420023B, 121420023C, 121520023D, 121520023E, 121620023D, 121620023E, 122120023A, 122120023B,, 122220023D, 122220023E, 122820023A, 122820023B, 122920023D, 122920023E, 122920023F

Where was it sold?

Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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