FDAClass IIOctober 31, 2018

NucliSENS¿ Magnetic Extraction Reagents recall

NucliSENS¿ Magnetic Extraction Reagents

Why was NucliSENS¿ Magnetic Extraction Reagents recalled?

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Reference # 200293, Lot # 17121501, Expiration date 11/28/2018

Product
NucliSENS¿ Magnetic Extraction Reagents
Recalling firm
BioMerieux SA
Quantity
42 units
Distribution
Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.
Recall date
October 31, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls