Qiagen recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1/V2) due to decreased reliability causing potential 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 (V1 and V2) because the test may run aborts, leading to repeated testing and delayed diagnosis. This affects labs using the product with specific lot numbers and expiration dates.
The test has a decreased performance reliability rate, meaning it may run abortions. When this happens, the test would need to be repeated, potentially delaying diagnosis of SARS-CoV-2 infection.
Labs and healthcare facilities using the QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2) with specific lot numbers and expiration dates. Users most at risk are those who may have to repeat tests due to run abortions.
Check for lot numbers: 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381. Products with expiration dates of 2023-10-06 or 2023-10-17 are affected.
Look for lot numbers listed: 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381.
Ensure the product's expiration date is 2023-10-06 or 2023-10-17.
No, this product is not sold in the US.
The test may run abortions, causing repeated testing and potential delays in diagnosis.
Check the lot number against the list: 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381. Also check expiration dates of 2023-10-06 or 2023-10-17.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-2246-2023 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-2246-2023 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.
