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PerkinElmer Life and Analytical Sciences, Wallac, OY recalls Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version)
Recalled May 9, 2018 · FDA recall Z-1541-2018 · PerkinElmer Life and Analytical Sciences, Wallac, OY
Hazard
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results. · FDA Class II
Units
8
Sold at
Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
Description
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
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.
Manufacturer(s)
PerkinElmer Life and Analytical Sciences, Wallac, OY
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →