Company: Perkin Elmer Life Sciences Inc.
Date of Enforcement Report 11/4/2015
Class lI:

PRODUCT

Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.Recall Number Z-0166-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
Perkin Elmer Life Sciences Inc., Turku, FL on 8/26/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6 units

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

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