Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2166-2014 · Posted 2014-08-07

Recalling FirmPerkinElmer Health Sciences, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-06-27
Date Terminated2015-04-06
Product Quantity13 devices

Reason for Recall

Potential for demographic information and test result to be mismatch.

Firm Action

PerkinElmer sent an Urgent Medical Device Recall letter on July 1, 2014, to all affected customers. The letter informed customers of the recall and provided instructions. Customers were asked to complete the enclosed response form and fax it to 1-330-825-8520. For additional information, customers were instructed to contact their local PerkinElmer representative or email [email protected]. Customers with questions were instructed to call 1-800-321-9632. option 1.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑