Device product
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Z-1541-2018
Product summary
- Event
- Event 79421
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-1541-2018
Official wording
Reason: Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
Code information: All software versions from 1.0 to 1.8 (current software version)
Distribution pattern: Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
Derived failure modes
-
Unknown
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.