FDA Device recall Z-1761-2017
Specimen Gate Laboratory
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Specimen Gate Laboratory by Perkinelmer Life And Analytical Sciences Wallac Oy, citing potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1761-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-07 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Perkinelmer Life And Analytical Sciences Wallac Oy |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA |
Product
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
Reason
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Identifiers
| code_info | Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1761-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.