FDA-Device2022-09-07Class II
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Qiagen Sciences LLC
Hazard
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
Sold states
IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
Affected count
22 kits
Manufactured in
19300 Germantown Rd, Germantown, MD, United States
Products
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1650-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief