Perkin Elmer Life Sciences Inc recalls Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qu…

Recall date

August 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0166-2016

FDA classification

Class II

Brand / firm

Perkin Elmer Life Sciences Inc

Sold / distributed

US distribution to FL, GA, and NV; and Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.