therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Reported: September 7, 2022 Initiated: July 20, 2022 #Z-1651-2022
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
Details
- Recalling Firm
- Qiagen Sciences LLC
- Units Affected
- 29 kits
- Distribution
- IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
- Location
- Germantown, MD
Frequently Asked Questions
What product was recalled? ▼
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711. Recalled by Qiagen Sciences LLC. Units affected: 29 kits.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1651-2022.
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