Reported Sep 22, 2021 · Ongoing

Verigene EP Amplification Reagent Kit Test

Luminex Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Luminex Corporation · 4088 Commercial Ave · Northbrook, IL · 60062-1829

Is this the product you have?

  • Verigene EP Amplification Reagent Kit Test
Lot codes and dates
  • ModelVerigene Enteric Pathogens (EP) Stool PREP KIT
  • Catalog Number30-002-023
  • Lots

    66 of 66 codes

    • 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
Amount recalled
4579 kits

Where it was sold

  • Nationwide

Why it was recalled

There is potential for false positive results.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Luminex Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.