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Recall Observatory FDA recall evidence

Device product

therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

Z-1651-2022

July 20, 2022

Class II

Product summary

Firm
Qiagen Sciences LLC
Event
Event 90691
Status
Ongoing
Classification
Class II
Quantity
29 kits
Official record key
device-enforcement:Z-1651-2022

Official wording

Reason: Increased 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

Code information: Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022

Distribution pattern: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Increased 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