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Recall Observatory FDA recall evidence

Device product

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

Z-0166-2016

August 24, 2015

Class II

Product summary

Firm
Perkin Elmer Life Sciences Inc
Event
Event 72013
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0166-2016

Official wording

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.

Code information: Software Version 1.6

Distribution pattern: US distribution to FL, GA, and NV; and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.