PerkinElmer Life and Analytical Sciences, Wallac, OY: Medical Device Recall in 2018 - (Recall #: Z-1541-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

Product Classification:

Class II

Date Initiated: November 17, 2017

Date Posted: May 9, 2018

Recall Number: Z-1541-2018

Event ID: 79421

Reason for Recall:

Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.

Status: Terminated

Product Quantity: 8

Code Information:

All software versions from 1.0 to 1.8 (current software version)

Distribution Pattern:

Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated