therascreen PIK3CA RGQ PCR Kit recall
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY…
Why was therascreen PIK3CA RGQ PCR Kit recalled?
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
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?
All lots
- Product
- therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY…
- Recalling firm
- Qiagen Sciences LLC
- Quantity
- 575 kits US
- Distribution
- CA, IN, MI, MN, NC, NJ, NM, OH, TX
- Recall date
- February 3, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)