Z-2166-2014Class II

PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6

Name: Z-2166-2014 PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6
Creator: PerkinElmer Health Sciences, Inc.
Published: 2014-06-27
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2014-06-27 / Terminated / root cause: software

FDA source

PerkinElmer Health Sciences, Inc. began a recall of 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... on 2014-06-27. FDA classified it as Class II and gives the reason as "Potential for demographic information and test result to be mismatch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2166-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-27
Posted: 2014-08-07
Terminated: 2015-04-06
Recalling firm: Revvity Health Sciences, Inc.
Product: 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 code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Potential for demographic information and test result to be mismatch.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 13 devices
Distribution: Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
Product codes and lots: Product Code: 5002-0500; Software Versions, 1.4 and 1.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2166-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2166-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)