FDAClass IIJanuary 11, 2023

Gene-up Reagent Gene-up Lysis KIT recall

GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057

Why was Gene-up Reagent Gene-up Lysis KIT recalled?

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

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?

UDI/DI 3573026387761, Batch Numbers: 1009334990

Product
GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
Recalling firm
Biomerieux Inc
Quantity
2 units
Distribution
US Nationwide distribution.
Recall date
January 11, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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