Qiagen Sciences LLC 2022-01-12 Health serious FDA
Health · FDA · Recall #FDA-Z-0455-2022
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 Recall
Issued January 12, 2022 · Qiagen Sciences LLC
In January 2022, Qiagen Sciences LLC recalled the QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
What you should do
- 1 Stop using QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Qiagen Sciences LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Qiagen Sciences LLC
- Category
- Health
- Recall date
- January 12, 2022
- Units affected
- Not reported
- Sold at
- Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.
- Recall number
- FDA-Z-0455-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Qiagen Sciences LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.