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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

QIAstat-Dx Respiratory Panel Plus Recalled for Risk of False Test Results

Agency Publication Date: March 31, 2025
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Summary

Qiagen Sciences LLC is recalling 445 units of the QIAstat-Dx Respiratory Panel Plus (Reference Number 691224) due to identified faulty cartridges. These diagnostic test kits are used in clinical laboratories to detect respiratory infections. Using a faulty cartridge during testing could lead to false test results, which may result in incorrect patient diagnoses or treatment delays. No incidents or injuries have been reported to date.

Risk

The faulty cartridges may provide inaccurate information about the presence of respiratory pathogens. False results can lead to patients receiving unnecessary treatments or failing to receive critical medical care for a serious infection.

What You Should Do

  1. This recall affects QIAstat-Dx Respiratory Panel Plus diagnostic kits sold under the Reference Number 691224 and Lot Number 178038604. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled cartridges immediately to avoid the risk of generating inaccurate laboratory results.
  3. Contact Qiagen Sciences LLC or your authorized medical distributor to arrange for the return, replacement, or correction of your inventory.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this safety notice.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: QIAstat-Dx Respiratory Panel Plus
Model / REF:
691224
Serial Numbers (200):
332168961
332168962
332168963
332168964
332168972
332168978
332168979
332168980
332168990
332168996
332169005
332169012
332169013
332169015
332169016
332169021
332169022
332169023
332169024
332169031
332169032
332169033
332169034
332169039
332169040
332169041
332169042
332169047
332169048
332169049
332169050
332169055
332169056
332169057
332169060
332169065
332169066
332169073
332169074
332169083
332169084
332169085
332169086
332169091
332169092
332169093
332169094
332169099
332169101
332169102
Lot Numbers:
178038604
UDI:
04053228047438

Quantity affected: 445 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96521
Status: Active
Manufacturer: Qiagen Sciences LLC
Sold By: Authorized Medical Distributors; Healthcare Facilities
Manufactured In: United States
Units Affected: 445 units
Distributed To: Alabama, California, District of Columbia, Florida, Indiana, Kansas, Kentucky, Massachusetts, Maine, Minnesota, New York, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.