Qiagen GmbH 2023-08-02 Health serious FDA
Health · FDA · Recall #FDA-Z-2215-2023
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and… Recall
Issued August 2, 2023 · Qiagen GmbH
In August 2023, Qiagen GmbH recalled the QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported
What you should do
- 1 Stop using QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Qiagen GmbH 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 GmbH
- Category
- Health
- Recall date
- August 2, 2023
- Units affected
- Not reported
- Sold at
- AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA
- Recall number
- FDA-Z-2215-2023
- Made in
- Germany
- Issuing agency
- FDA
In context
- Qiagen GmbH has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.