FDA Device recall Z-2166-2014
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6
- FDA Device
- Class II
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class II recall of PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6 by Perkinelmer Health Sciences, citing potential for demographic information and test result to be mismatch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2166-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-27 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Perkinelmer Health Sciences |
| Distribution | FL, GA, MA, NV |
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.
Reason
Potential for demographic information and test result to be mismatch.
Identifiers
| code_info | Product Code: 5002-0500; Software Versions, 1.4 and 1.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2014%22
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