Perkin Elmer Specimen Gate — Class II medical device recall Z-0166-2016
Terminated recall by Perkin Elmer Life Sciences Inc, reported 2015-11-04, distributed in FL, GA, NV. It would be possible for an abnormal analytical test result value from an affected newborn to be reported with
| Recall number | Z-0166-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perkin Elmer Life Sciences Inc, Turku, N/A, Finland |
| Recall initiated | 2015-08-24 |
| Classified | 2015-10-26 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2021-01-21 |
| Distributed | FL, GA, NV |
| Countries outside the US | CA |
| Quantity | 6 units |
Product
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Reason for recall
It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
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-0166-2016. 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.