Respiratory Diagnostic Test Kits Recalled for Decreased Performance Reliability
Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kits are recalled due to decreased performance reliability. Failed test runs could require sample retesting, potentially delaying diagnosis.
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 medical device recall with identified performance reliability issues. No illnesses, injuries, or hospitalizations reported. The hazard is operational risk of delayed diagnosis from failed test runs, which is a risk-of-harm situation but lacks reported clinical consequences.
Plain-English summary
Qiagen GmbH is recalling 386 units of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (REF 691223), an FDA-cleared qualitative test for analyzing nasopharyngeal swab samples from patients suspected of respiratory infection.
The FDA identified a decreased performance reliability rate in the recalled lots. The test kits may experience run abortions—failed test runs—which would require samples to be retested. This could delay diagnosis and patient care decisions.
The recalled kits are lot numbers 175010704 and 175011354, with expiration dates of 2023-10-06 and 2023-10-17. Affected products were distributed to healthcare facilities in DC, Alabama, California, Florida, Georgia, Maine, North Carolina, New York, Oregon, and Texas, as well as numerous international locations.
Facilities that have received these kits should discontinue use of the recalled lots and contact Qiagen for instructions regarding replacement products or refunds.
The recalled product
- Product
- QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
- Manufacturer
- Qiagen GmbH
- Hazard
- test-failure
- delayed-diagnosis
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 (2)
- GTIN 14053228038846 LOT Numbers: 175010704
- 175011354 Exp. Date: 2023-10-06 and 2023-10-17
Distribution
Distributed in 14 states:
- AL
- CA
- DC
- DE
- FL
- GA
- ID
- IN
- ME
- NC
- NY
- OR
- TN
- TX
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