Qiagen recalls Therascreen KRAS RGQ PCR Kit (24) with expiry dates March 2023 or later due to potential false negative results from a dilution error in specific error flags.
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
Qiagen is recalling Therascreen KRAS RGQ PCR Kit (24) products with expiry dates from March 2023 onward. The recall is due to a potential false negative result if a specific error flag is misinterpreted during the dilution step of CRC tissue samples.
The kit's handbook revision (Rev13) indicates a dilution step should be taken when the Flag SAMPLE_INT_CTRL_FAIL appears. If CRC tissue is diluted incorrectly, it could lead to false negative results in detecting KRAS mutations.
Users of the Therascreen KRAS RGQ PCR Kit (24) with expiry dates March 2023 or later are affected. Laboratory personnel handling the kit are most at risk due to potential false negative results.
Check for the Therascreen KRAS RGQ PCR Kit (24) with an expiry date of March 2023 or later. The product is sold under the GTIN number 04053228002048.
Verify the expiry date on the kit label; recall applies to all lots with expiry dates March 2023 or later.
The recall is due to a potential false negative result if a specific error flag (SAMPLE_INT_CTRL_FAIL) is misinterpreted during the dilution step of CRC tissue samples.
The official recall notice does not specify a remedy, so no action is required beyond checking the expiry date.
The recall addresses potential false negative results in lab testing, not physical injury risks.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-2665-2023 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-2665-2023 from Qiagen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
