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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

Mandated?Voluntary: Firm initiated
Recall NumberZ-0455-2022
Event ID89130
Event DescriptionQIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Product TypeDevices
DistributionDomestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.
Quantity376 kits
Recall ReasonThe 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 Classification20220112
Device Code InfoLOT 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 Date20220105
Recall Initiation Date20211108
Recalling FirmQiagen Sciences LLC
Initial Notification Letter
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