Reported Apr 20, 2022 · Ongoing
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
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 Processor SP
- Model Numbers10-0000-07 and 10-0000-07-R
- Lot codes and dates
- Model Number 10-0000-07
- Serial Numbers
130420541634708217215010Model Number 10-0000-07-R
- Serial Numbers18079010
- Amount recalled
- 4 units
Where it was sold
Why it was recalled
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
This product could cause temporary or reversible health problems — stop using it.
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