Respiratory diagnostic panel fails to produce test results
Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel may fail to produce diagnostic results due to software errors in affected cartridges. Test runs will abort with error codes, leaving no test results available.
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: This is an FDA Class II diagnostic device with confirmed functional failure preventing test result reporting. Although no illnesses or injuries have been reported, the failure involves high-risk respiratory pathogens including SARS-CoV-2, influenza, and RSV, creating potential risk of missed diagnoses and delayed treatment.
Plain-English summary
Qiagen GmbH is recalling 368 kits of its QIAstat-Dx® Respiratory SARS-CoV-2 Panel, a diagnostic test designed to detect and identify nucleic acids from SARS-CoV-2 and 22 other respiratory pathogens and organisms, including influenza A and B, respiratory syncytial virus (RSV), human metapneumovirus, parainfluenza viruses, coronaviruses, rhinovirus, and others.
When cartridges from affected serial numbers are used, the device will encounter error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4), causing the test run to abort. When these errors occur, no test results are reported, leaving clinicians without the diagnostic information needed.
The recalled kits were distributed to locations in Alabama, Arkansas, California, District of Columbia, Florida, Georgia, Idaho, Kansas, Kentucky, Maryland, Minnesota, New Jersey, New York, Pennsylvania, South Carolina, Texas, and Virginia. The affected lot number is 175010712, with serial numbers ranging from 330559516 to 330559783. Laboratories and clinics using these cartridges should discontinue use of affected units and contact Qiagen for replacement or return information.
The recalled product
- Product
- QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapn
- Manufacturer
- Qiagen GmbH
- Hazard
- diagnostic-failure
Distribution
Distributed in 17 states:
- AL
- AR
- CA
- DC
- FL
- GA
- ID
- KS
- KY
- MD
- MN
- NJ
- NY
- PA
- SC
- TX
- VA
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