Specimen Gate Laboratory — Class II medical device recall Z-1761-2017
Terminated recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, reported 2017-04-19, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
| Recall number | Z-1761-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, N/A, Finland |
| Recall initiated | 2017-03-07 |
| Classified | 2017-04-07 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2021-05-10 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA |
| Countries outside the US | BR, CA |
| Quantity | 29 |
| Reason classes | software |
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 for recall
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
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-1761-2017. 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.