FDAClass IISeptember 7, 2022

therascreen FGFR RGQ RT-PCR Kit recall

therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

Why was therascreen FGFR RGQ RT-PCR Kit recalled?

Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects

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?

Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022

Product
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Recalling firm
Qiagen Sciences LLC
Quantity
29 kits
Distribution
IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
Recall date
September 7, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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