therascreen FGFR RGQ Kit Recalled for Increased False Positive Results
Qiagen's therascreen FGFR RGQ RT-PCR Kit is being recalled for increased false positive results in 29 distributed kits. False positives could lead to incorrect lab reports and inappropriate cancer treatment for patients.
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: This FDA Class II device presents risk of harm through false positive diagnostic results that could lead to inappropriate cancer treatment. No illnesses or injuries have been reported, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The therascreen FGFR RGQ RT-PCR Kit (Ref 874711), manufactured by Qiagen Sciences LLC, is being recalled due to an increased occurrence rate of false positive results. This is an FDA Class II in vitro diagnostic device. Affected lots include lot number 172017804 (expiration 10.11.2022) and lot number 169046610 (expiration 12.06.2022), with 29 total kits distributed.
False positive results from this kit could be incorrectly reported by laboratories as positive patient samples. Such incorrect reports could lead to patients being exposed to inappropriate or suboptimal anti-cancer treatment and potentially experiencing unnecessary side effects from treatment.
The affected kits were distributed to locations in Indiana, North Carolina, Minnesota, and Texas, as well as internationally to Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, and Thailand.
Laboratories and healthcare providers should review the FDA recall notice and contact Qiagen Sciences LLC for guidance on handling affected kits and whether patient results require retesting or re-evaluation.
The recalled product
- Product
- therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
- Manufacturer
- Qiagen Sciences LLC
- Affected units
- 29
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: 172017804 Exp Date: 10.11.2022 169046610 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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