Reported May 25, 2022 · Ongoing

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

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 · 12212 Technology Blvd · Austin, TX · 78727-6101

Is this the product you have?

  • Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Lot codes and dates
  • Serial Numbers for 10-0000-07
    • 17340003
    • 19044007
    • 20133004
    • 18128002
    • 18214004
    • 12061048
    • 18191010
    • 13193254
    • 13051068
    • 21029902
    • 16277059
    • 19233005
    • 11250096
    • 14069051
    • 18255003
    *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22
  • for 10-0000-07R18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22
  • for 10-0000-07R18226007 and 16242043 Serial Numbers added 7.14.22
  • for 10-0000-07
    • 17062030
    • 18235008 and 19192006
Amount recalled
24 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 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.