Device product
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Z-1683-2023
Product summary
- Event
- Event 92298
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 347 kits
- Official record key
device-enforcement:Z-1683-2023
Official wording
Reason: Faulty cartridges in the lot could result in false test results.
Code information: GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.
Distribution pattern: US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.
Derived failure modes
-
Unknown
Faulty cartridges in the lot could result in false test results.