FDA Device recall Z-0166-2016
Perkin Elmer Specimen Gate, Screening Center
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of Perkin Elmer Specimen Gate, Screening Center by Perkin Elmer Life Sciences, citing 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 resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0166-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-24 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Perkin Elmer Life Sciences |
| Distribution | FL, GA, NV |
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
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.
Identifiers
| code_info | Software Version 1.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0166-2016%22
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