Respiratory Diagnostic Cartridges Recalled for Risk of False Test Results
Qiagen is recalling 445 QIAstat-Dx Respiratory Panel Plus cartridges due to faulty units that could produce false test results. Affected devices distributed to 12 US states should not be used.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic device with cartridges that could produce false test results, posing a risk of harm from incorrect clinical decisions. No illnesses or injuries have been reported in the source text, and the hazard is theoretical, placing this at Score 3 per the rubric.
Plain-English summary
Qiagen Sciences LLC is recalling 445 units of QIAstat-Dx Respiratory Panel Plus cartridges (reference 691224, lot 178038604) distributed to healthcare facilities in 12 US states (AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX). Certain cartridges in this lot have been identified as faulty and may produce false test results when used for patient sample testing.
False test results from diagnostic cartridges pose a risk to patient care, as they could lead to incorrect clinical decisions. The affected cartridges are identified by specific serial numbers provided by the manufacturer.
Healthcare facilities that have received affected units should discontinue use immediately and verify their cartridge serial numbers against the provided list. Providers should contact Qiagen for replacement or return instructions.
Patients who may have been tested using an affected cartridge should consult with their healthcare provider regarding the reliability of their test results.
The recalled product
- Product
- Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
- Manufacturer
- Qiagen Sciences LLC
- Hazard
- false-test-results
- faulty-cartridge
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- REF 691224
- Lot 178038604
- UDI-DI: 04053228047438
Distribution
Distributed in 12 states:
- AL
- CA
- DC
- FL
- IN
- KS
- KY
- MA
- ME
- MN
- NY
- TX
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