Reported Oct 14, 2020 · Ongoing

VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying…

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 Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Lot codes and dates
  • Catalogue Number10-0000-07 Serial No. 14230205
  • UDI Code00857573006010
Amount recalled
1 system

Where it was sold

Why it was recalled

No results/incorrect results due to failure of the hybridization heater.

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, 6:59 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.