QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk
Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.
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 recall with risk-of-harm (false SARS-CoV-2 test results) where no illnesses or injuries have been reported. The source explicitly states only the theoretical potential for false results, not actual incidents.
Plain-English summary
Qiagen Sciences LLC is recalling 347 QIAstat-Dx Respiratory SARS-CoV-2 Panel test kits because cartridges in the affected lot could produce false test results.
The recall affects Lot 175011350 with specific serial numbers distributed nationwide to healthcare facilities in California, Florida, Illinois, Maryland, Mississippi, New York, Oklahoma, Pennsylvania, and Tennessee.
Healthcare providers and laboratories that received these kits should stop using them and verify their serial numbers against the recall information. Any kits matching the affected lot and serial numbers should be removed from service and the manufacturer contacted. False test results could lead to misdiagnosis and improper patient care decisions.
The recalled product
- Product
- QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
- Manufacturer
- Qiagen Sciences LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-test-results
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 (10)
- GTIN 14053228038846
- Lot 175011350
- Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655
- 330569651
- 330569650
- 330569646
- 330569645
- 330569644
- 330569643
- 330569641.
Distribution
Distributed nationwide across the United States.
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