Qiagen QIAstat-Dx SARS-CoV-2 Test Cartridges May Give False Results
Qiagen recalls specific SARS-CoV-2 test cartridges that may produce false negative results due to faulty manufacturing. Affected units include certain lot and serial numbers from the QIAstat-Dx Respiratory SARS-CoV-2 Panel test.
Lower-risk recall
Faulty cartridges in the lot could result in false test results.
Contact the company
What happened, in plain English
Qiagen is recalling specific cartridges for their SARS-CoV-2 test that could give false negative results. This means the test might not detect the virus when it's actually present, which could lead to incorrect health decisions. Read more at govinfonow.com/recall/58491-qiagen-qiastat-dx-sars-cov-2-test-cartridges-may-give.
Source Summary by GovInfoNow · govinfonow.com/recall/58491-qiagen-qiastat-dx-sars-cov-2-test-cartridges-may-give · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1683-2023
Cite this page
“Qiagen QIAstat-Dx SARS-CoV-2 Test Cartridges May Give False Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58491-qiagen-qiastat-dx-sars-cov-2-test-cartridges-may-give. Based on FDA recall #Z-1683-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1683-2023%22&limit=1).
Why it’s dangerous
The faulty cartridges may produce false negative results, meaning the test could incorrectly show no virus when the virus is actually present. This could lead to people not taking necessary health precautions even when infected.
Who’s affected
People who purchased the QIAstat-Dx Respiratory SARS-CoV-2 Panel test cartridges with the specific lot and serial numbers listed in the recall. Those using the test for home virus screening are most at risk of false negatives.
How to tell if you have this one
Check the lot number (175011350) and serial numbers between 330568064 to 330568597 and specific serial numbers listed (330569655, 330569651, etc.). The product is sold under the QIAstat-Dx Respiratory SARS-CoV-2 Panel test.
- Brand
Qiagen- Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223- Category
Medical device
What to do — step by step
Check Cartridge Details
Verify the lot number (175011350) and serial numbers against the list provided in the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Maryland, Mississippi, New York, Oklahoma, Pennsylvania, Tennessee.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1683-2023 (April 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1683-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.