Company: PerkinElmer Life and Analytical Sciences, Wallac, OY
Date of Enforcement Report 5/9/2018
Class II:
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. Recall Number Z-1541-2018
REASON
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
RECALLING FIRM/MANUFACTURER
PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku ,Finland on 11/17/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8
DISTRIBUTION
Worldwide Distribution – US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.