FDAClass IIApril 20, 2022

Verigene Processor SP recall

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

Why was Verigene Processor SP recalled?

Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010

Product
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Recalling firm
Luminex Corporation
Quantity
4 units
Distribution
US: TX, CT, LA
Recall date
April 20, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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