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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