PerkinElmer Health Sciences, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2166-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

Product Classification:

Class II

Date Initiated: June 27, 2014

Date Posted: August 13, 2014

Recall Number: Z-2166-2014

Event ID: 68670

Reason for Recall:

Potential for demographic information and test result to be mismatch.

Status: Terminated

Product Quantity: 13 devices

Code Information:

Product Code: 5002-0500; Software Versions, 1.4 and 1.6

Distribution Pattern:

Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK

Voluntary or Mandated:

Voluntary: Firm initiated