CLASS II ONGOING Device recall · Reported 7 Sep 2022 · FDA Enforcement Report
Fgfr Rgq Rt-pcr Kit (Ruo, not Ivd) recalled by Qiagen Sciences
Qiagen Sciences is recalling Fgfr Rgq Rt-pcr Kit (Ruo, not Ivd), distributed in Indiana, Minnesota, North Carolina, Texas. The recall was initiated on 20 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1652-2022
- FDA event ID
- 90691
- Recalling firm
- Qiagen Sciences, Germantown, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jul 2022
- FDA classified
- 29 Aug 2022
- Reported
- 7 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Jul 2022 | Recall initiated by company | |
| 29 Aug 2022 | Classified by FDA | +40 days |
| 7 Sep 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Where it was distributed
IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
Questions about this recall
Why was it 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 lots are affected?
Lot number: 169047135 Exp Date: 12.06.2022 172017806 Exp. Date: 10.11.2022
Where was it sold?
IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 90691| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | therascreen Fgfr Rgq Rt-pcr Kit (CE Ivd recalled by Qiagen Sciences | Qiagen Sciences | Other | 4 states | |
| CLASS II | therascreen Fgfr Rgq Rt-pcr kit (US Ivd) recalled by Qiagen Sciences | Qiagen Sciences | Other | 4 states |
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|---|---|---|---|---|---|
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