RT-PCR Kit Recalled Due to False Positive Test Results
Qiagen's FGFR RGQ RT-PCR Kit may produce false positive results, leading to incorrect lab reports. This could expose cancer patients to inappropriate or suboptimal 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 with increased false positive test results that could lead to inappropriate cancer treatment. No illnesses or injuries have been reported; the harm is potential only.
Plain-English summary
Qiagen Sciences LLC is recalling its FGFR RGQ RT-PCR Kit (reference 8747010), a diagnostic kit used to test for specific genetic markers. The recall affects 9 kits that were distributed to healthcare facilities in Indiana, North Carolina, Minnesota, Texas, and to international locations including Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, and Thailand. The affected lots are 169047135 (expiration 12.06.2022) and 172017806 (expiration 10.11.2022).
These kits have an increased rate of false positive results, meaning the test may incorrectly indicate the presence of a genetic marker when it is not actually present. False positive results could be reported by laboratories without correction, leading physicians and patients to act on inaccurate diagnostic information.
This kit is used to guide cancer treatment decisions. A false positive result could cause patients to receive inappropriate or suboptimal anti-cancer treatment and to experience unnecessary side effects from medications that would not otherwise be needed. Patients and healthcare providers should contact Qiagen Sciences LLC regarding any tests performed with these kits, and laboratories should review results from affected lots for accuracy.
The recalled product
- Product
- FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
- Manufacturer
- Qiagen Sciences LLC
- Affected units
- 9
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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