Qiagen QIAstat-Dx Respiratory Panel Plus: Faulty Cartridges May Cause False Test Results
Qiagen recalls QIAstat-Dx Respiratory Panel Plus cartridges with serial numbers listed. Faulty cartridges may cause false test results if used for sample testing. Affected units include specific serial numbers.
Lower-risk recall
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Contact the company
What happened, in plain English
Qiagen is recalling QIAstat-Dx Respiratory Panel Plus cartridges that may cause false test results if used for sample testing. This affects specific serial numbers listed in the recall notice. Read more at govinfonow.com/recall/52639-qiagen-qiastat-dx-respiratory-panel-plus-faulty-cartridges-may-cause.
Source Summary by GovInfoNow · govinfonow.com/recall/52639-qiagen-qiastat-dx-respiratory-panel-plus-faulty-cartridges-may-cause · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1504-2025
Cite this page
“Qiagen QIAstat-Dx Respiratory Panel Plus: Faulty Cartridges May Cause False Test Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52639-qiagen-qiastat-dx-respiratory-panel-plus-faulty-cartridges-may-cause. Based on FDA recall #Z-1504-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1504-2025%22&limit=1).
Why it’s dangerous
Faulty cartridges in the QIAstat-Dx Respiratory Panel Plus may produce false test results when used for sample testing. This could lead to incorrect health assessments if the cartridges are not replaced with working ones.
Who’s affected
Users of the QIAstat-Dx Respiratory Panel Plus who have the affected serial numbers listed in the recall notice. Laboratory personnel and healthcare providers using the product are most at risk.
How to tell if you have this one
Check the serial number on the QIAstat-Dx Respiratory Panel Plus cartridge. Affected units have specific serial numbers listed in the recall notice (e.g., 332168961, 332168962, etc.).
- Brand
Qiagen- Category
Medical device
What to do — step by step
Check Serial Number
Verify the serial number on the QIAstat-Dx Respiratory Panel Plus cartridge to see if it matches the affected list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in 11 states and D.C..
FDA distribution: “US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, District of Columbia, Florida, Indiana, Kansas, Kentucky, Maine, Massachusetts, Minnesota, New York, Texas.
Recall timeline
FDA published this recall 28 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-1504-2025 (March 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1504-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.