Qiagen Sciences LLC Recall 89130
Description: QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Qiagen Sciences LLC Recall 89130 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0455-2022 |
| Event ID | 89130 |
| Event Description | QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 |
| Product Type | Devices |
| Distribution | Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution. |
| Quantity | 376 kits |
| Recall Reason | The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur. |
| Device Classification | 20220112 |
| Device Code Info | LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223 Serial Numbers: 412092551 412092559 412092552 412092560 412092553 412092561 412092554 412092563 412092555 412092564 412092556 412092565 412092557 412092566 412092558 412092567 |
| Center Classification Date | 20220105 |
| Recall Initiation Date | 20211108 |
| Recalling Firm | Qiagen Sciences LLC |
| Initial Notification | Letter |
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