FGFR cancer diagnostic kit recalled due to increased false positive results
Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving diagnostic error that could lead to inappropriate cancer treatment. No illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm product where injury has not yet been reported scores at most 3 (High).
Plain-English summary
Qiagen Sciences LLC is recalling therascreen FGFR RGQ RT-PCR kits (REF 874721) due to an increased occurrence rate of false positive results. The affected kits are in vitro diagnostic devices used to detect FGFR mutations in cancer patients.
False positive results from these kits could be incorrectly reported from the laboratory and lead patients to receive inappropriate or suboptimal anti-cancer treatment. Patients exposed to incorrect treatment based on false positive results could unnecessarily experience treatment side effects.
The recall affects 22 kits distributed to laboratories in Indiana, North Carolina, Minnesota, and Texas, as well as international locations including Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, and Thailand. Affected lots include lot number 172017274 (expiration 10.11.2022) and lot number 169046366 (expiration 12.06.2022).
The recalled product
- Product
- therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
- Manufacturer
- Qiagen Sciences LLC
- Category
- Medical Device — Diagnostic Test
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 172017274 Exp Date: 10.11.2022 169046366 Exp. Date: 12.06.2022
Distribution
Part of a larger recall action
This product is one of 3 recalled by Qiagen Sciences LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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