therascreen ¿KRAS RGQ PCR Kit recall
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in…
Why was therascreen ¿KRAS RGQ PCR Kit recalled?
Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid
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?
GTIN number: 04053228002048 All lots that have an expiry date of March 2023 or later
- Product
- therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in…
- Recalling firm
- Qiagen GmbH
- Quantity
- N/A
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, KS, MA, NC,NY,OR, PA, TN, TX and the countries of KR, CN
- Recall date
- October 11, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)