Specimen Gate Screening Center — Class II medical device recall Z-1541-2018
Terminated recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, reported 2018-05-09, distributed in GA. Potential errors in patient results generated by the Screening Center product that include both false negative
| Recall number | Z-1541-2018 |
|---|---|
| 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 | 2017-11-17 |
| Classified | 2018-04-27 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2021-08-12 |
| Distributed | GA |
| Countries outside the US | BE, CA, DK, GB, IT |
| Quantity | 8 |
| Model numbers | 5002-0500 |
Product
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Reason for recall
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
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-1541-2018. 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.