Lower risk Medical device recall · FDA · Published November 8, 2021

Qiagen QIAstat-Dx SARS-CoV-2 Panel Cartridges May Give False Results

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0455-2022Medical device Qiagen ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmQiagen Sciences LLC19300 Germantown Rd · Germantown, MD 20874-1415

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61559-qiagen-qiastat-dx-sars-cov-2-panel-cartridges-may-give.

Source Summary by GovInfoNow · govinfonow.com/recall/61559-qiagen-qiastat-dx-sars-cov-2-panel-cartridges-may-give · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0455-2022

Cite this page

“Qiagen QIAstat-Dx SARS-CoV-2 Panel Cartridges May Give False Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61559-qiagen-qiastat-dx-sars-cov-2-panel-cartridges-may-give. Based on FDA recall #Z-0455-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0455-2022%22&limit=1).

The FDA announced on 2021-11-08 that Qiagen Sciences LLC is recalling QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to faulty cartridges that may cause false test results. The agency stated the recall addresses incorrect primer-probe mixes in specific lots.

How to tell if you have it

Brand: Qiagen
Product: QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075)
REF: 691223
UPC: 14053228038846
Lot: 210209
Serial Numbers: 412092551, 412092559, 412092552, 412092560, 412092553, 412092561, 412092554, 412092563, 412092555, 412092564, 412092556, 412092565, 412092557, 412092566, 412092558, 412092567
Distribution: AL, DC, KY, MD, ME, NJ, OK, PA, TX

The hazard

The firm identified sixteen (16) faulty cartridges in LOT 210209 containing incorrect primer-probe mixes. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.

Context

GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since 2018-07-23. Other recent recalls of similar products include Qiagen QIAstat-Dx Respiratory Panel Plus (2025-03-12), Qiagen QIAcube Connect MDx Recall (2024-06-03), and Qiagen EZ2 Connect MDx-IVD Recall (2024-03-04). Other recent recalls of similar products include HardyDisk AST Cefiderocol 30μg FDC30 (2026-06-08) and Abbott i-STAT EG6+ Cartridges (2026-04-01).

How to tell if you have this one

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.

Brand
Qiagen
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Cartridge Lot Number
Look for the lot number 210209 on the cartridge to determine if it is affected.

Where it went and when

Where it was distributed

Distributed in 8 states and D.C..

FDA distribution: “Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, District of Columbia, Kentucky, Maine, Maryland, New Jersey, Oklahoma, Pennsylvania, Texas.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Nov 8, 2021Firm started the recall
Jan 5, 2022FDA classified it Class II
Jan 12, 2022Published in FDA’s Enforcement Report
Mar 29, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61559-qiagen-qiastat-dx-sars-cov-2-panel-cartridges-may-give">Qiagen QIAstat-Dx SARS-CoV-2 Panel Cartridges May Give False Results (GovInfoNow)</a>

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-0455-2022 (November 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0455-2022 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.