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Qiagen Sciences LLC Recall 90691

Description: FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

Qiagen Sciences LLC Recall 90691 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1652-2022
Event ID90691
Event DescriptionFGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Product TypeDevices
DistributionIN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
Quantity9 kits
Recall ReasonIncreased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
Device Classification20220907
Device Code InfoLot number: 169047135 Exp Date: 12.06.2022 172017806 Exp. Date: 10.11.2022
Center Classification Date20220829
Recall Initiation Date20220720
Recalling FirmQiagen Sciences LLC
Initial Notification E-Mail
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