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Perkin Elmer Life Sciences Inc recalls Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qu
Recalled November 4, 2015 · FDA recall Z-0166-2016 · Perkin Elmer Life Sciences
Hazard
It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect. · FDA Class II
Units
6 units
Sold at
US distribution to FL, GA, and NV; and Canada
Description
It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
Product
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Manufacturer(s)
Perkin Elmer Life Sciences Inc
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →