medical Class II Updated 2018-05-09

PerkinElmer Life and Analytical Sciences, Wallac, OY recalls Specimen Gate Screening Center, Part Number 5002-0500, All s

Recalled 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.

Hazard / Issue

Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.

Issued by

FDA

Distribution: Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
Lot/Code Info: All software versions from 1.0 to 1.8 (current software version)
View official government recall

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