Qiagen recalls 16 faulty SARS-CoV-2 test cartridges (LOT 210209) that may cause false negative or positive results. Affected units have specific serial numbers.
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.
Qiagen is recalling 16 faulty SARS-CoV-2 test cartridges that could produce false negative or false positive results. This means test results might be inaccurate if these cartridges are used.
The cartridges contain incorrect primer-probe mixes in the reaction chambers. If used, they can cause false negative, false positive, or both types of inaccurate results for SARS-CoV-2 testing.
Users of the QIAstat-Dx Respiratory SARS-CoV-2 Panel who purchased the faulty cartridges (LOT 210209) with specific serial numbers are affected. Laboratory staff and healthcare professionals using these cartridges for testing are most at risk.
Check for the lot number 210209 on the cartridge. Affected units have specific serial numbers listed in the recall notice: 412092551, 412092552, 412092553, 412092554, 412092555, 412092556, 412092557, 412092558, 412092559, 412092560, 412092561, 412092562, 412092563, 412092564, 412092565, 412092566, 412092567.
Look for the lot number 210209 on the cartridge to determine if it is affected.
Qiagen identified 16 faulty cartridges in LOT 210209 that contain incorrect primer-probe mixes, which could cause false negative or false positive results.
The recall notice does not specify a remedy for affected cartridges. Check the lot number and serial numbers to determine if your cartridge is affected.
Affected cartridges have the lot number 210209 and specific serial numbers listed in the recall notice: 412092551 through 412092567.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-0455-2022 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-0455-2022 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.
