therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
Reported: February 3, 2021 Initiated: December 11, 2020 #Z-0937-2021
Product Description
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
Reason for Recall
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.
Details
- Recalling Firm
- Qiagen Sciences LLC
- Units Affected
- 575 kits US
- Distribution
- CA, IN, MI, MN, NC, NJ, NM, OH, TX
- Location
- Germantown, MD
Frequently Asked Questions
What product was recalled? ▼
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121. Recalled by Qiagen Sciences LLC. Units affected: 575 kits US.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0937-2021.
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