therascreen KRAS RGQ PCR Kit recall
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Why was therascreen KRAS RGQ PCR Kit recalled?
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
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?
All lot numbers. GTIN number: 04053228002048
- Product
- therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
- Recalling firm
- Qiagen Sciences LLC
- Quantity
- 435 kits
- Distribution
- AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
- Recall date
- April 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)