Qiagen recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel due to potential run abortions causing delayed diagnosis. Affected units have specific lot numbers and expiration dates.
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Qiagen is recalling its QIAstat-Dx Respiratory SARS-CoV-2 Panel test kit because it can sometimes fail during testing, requiring retesting and delaying diagnosis. This affects tests purchased with specific lot numbers and expiration dates.
The test kit can sometimes stop working during the testing process (run abortions), which means the sample would need to be retested. This could delay diagnosis of SARS-CoV-2 infections, potentially affecting timely treatment.
Healthcare professionals using the test kit for respiratory infections are affected. Those who have the specific lot numbers or expiration dates listed are most at risk.
Check the lot numbers on the packaging: 175010704 or 175011354. The expiration date is either October 6, 2023 or October 17, 2023.
Look for lot numbers 175010704 or 175011354 on the packaging.
The recall is due to a decreased performance reliability rate, which can cause run abortions and require retesting, potentially delaying diagnosis.
Check the lot numbers and expiration dates on the packaging. If you have the affected lot numbers (175010704 or 175011354) with expiration dates of October 6, 2023 or October 17, 2023, you may need to contact Qiagen for guidance.
The recall record does not mention a specific fix or remedy. The manufacturer is asking users to check the lot numbers and expiration dates.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-2245-2023 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-2245-2023 from Qiagen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
