Perkin Elmer Life Sciences Inc: Medical Device Recall in 2015 - (Recall #: Z-0166-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 24, 2015

Date Posted: November 4, 2015

Recall Number: Z-0166-2016

Event ID: 72013

Reason for Recall:

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.

Status: Terminated

Product Quantity: 6 units

Code Information:

Software Version 1.6

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated