Qiagen recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel cartridges with specific serial numbers that cause test failures due to error codes 0xY0003EA and 0xY00045A. Affected units may not report results correctly.
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
Qiagen is recalling QIAstat-Dx Respiratory SARS-CoV-2 Panel cartridges with specific serial numbers. Using these cartridges can cause the test to abort with error codes, meaning no results will be reported. This affects labs and healthcare facilities that use the product for coronavirus testing.
Cartridges with affected serial numbers may trigger error codes (0xY0003EA and 0xY00045A) during testing, causing the test to abort and no results to be reported. This happens when the cartridges are used in the QIAstat-Dx system.
Healthcare facilities and labs that use the QIAstat-Dx Respiratory SARS-CoV-2 Panel for coronavirus testing are most affected. The recall targets specific serial numbers of the test cartridges.
Check the serial number on the cartridge. Affected units have serial numbers from 330559516 to 330559783. The product is sold under the QIAstat-Dx Respiratory SARS-CoV-2 Panel label.
Look for the serial number on the cartridge, which should be between 330559516 and 330559783.
Using affected cartridges can trigger error codes 0xY0003EA and 0xY00045A, leading to a test abortion with no results reported.
Check the serial number on the cartridge; affected units have serial numbers from 330559516 to 330559783.
The recall does not specify a remedy, so contact Qiagen directly for guidance on handling affected cartridges.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-2215-2023 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-2215-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
