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
Status | Completed |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0937-2021 |
Event ID | 87047 |
Event 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 |
Product Type | Devices |
Distribution | CA, IN, MI, MN, NC, NJ, NM, OH, TX |
Quantity | 575 kits US |
Recall Reason | 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. |
Device Classification | 20210203 |
Device Code Info | All lots |
Center Classification Date | 20210128 |
Recall Initiation Date | 20201211 |
Recalling Firm | Qiagen Sciences LLC |
Initial Notification | |
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