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Qiagen Sciences LLC Recall 87047

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

Qiagen Sciences LLC Recall 87047 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0937-2021
Event ID87047
Event Descriptiontherascreen 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
Product TypeDevices
DistributionCA, IN, MI, MN, NC, NJ, NM, OH, TX
Quantity575 kits US
Recall ReasonKit 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.
Device Classification20210203
Device Code InfoAll lots
Center Classification Date20210128
Recall Initiation Date20201211
Recalling FirmQiagen Sciences LLC
Initial Notification E-Mail
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