PerkinElmer Specimen Gate Screening Center software — Class II medical device recall Z-2166-2014
Terminated recall by PerkinElmer Health Sciences, Inc., reported 2014-08-13, distributed in FL, GA, MA, NV. Potential for demographic information and test result to be mismatch.
| Recall number | Z-2166-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Health Sciences, Inc., Waltham, MA, United States |
| Recall initiated | 2014-06-27 |
| Classified | 2014-08-07 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2015-04-06 |
| Distributed | FL, GA, MA, NV |
| Countries outside the US | BE, CA, GB, IE, IT, SA |
| Quantity | 13 devices |
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 for recall
Potential for demographic information and test result to be mismatch.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2166-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.