Recall Z-1651-2022— Qiagen Sciences LLC
Class II · Ongoing
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2022-07-20. FDA's recall record names no specific 510(k) clearance for this event. Product: therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711. 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.
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-20
- Firm location
- Germantown, MD, United States
Product description
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.