CLASS II Device recall · Reported 3 Feb 2021 · FDA Enforcement Report
therascreen PIK3CA RGQ PCR Kit US IVD product- aid recalled
Qiagen Sciences is recalling therascreen PIK3CA RGQ PCR Kit US IVD product- aid clinicians in identifying breast, distributed in 9 states. The recall was initiated on 11 Dec 2020 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-0937-2021
- FDA event ID
- 87047
- Recalling firm
- Qiagen Sciences, Germantown, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Dec 2020
- FDA classified
- 28 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Dec 2020 | Recall initiated by company | |
| 28 Jan 2021 | Classified by FDA | +48 days |
| 3 Feb 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
Product as listed by the FDA
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
Where it was distributed
CA, IN, MI, MN, NC, NJ, NM, OH, TX
CaliforniaIndianaMichiganMinnesotaNorth CarolinaNew JerseyNew MexicoOhioTexas
Questions about this recall
Why was it recalled?
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
Which lots are affected?
All lots
Where was it sold?
CA, IN, MI, MN, NC, NJ, NM, OH, TX
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.
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