Drug recall
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and…
FDA recall event 72013 · Class II · Perkin Elmer Life Sciences Inc
Key facts
| Event ID | 72013 |
|---|---|
| Recall numbers | Z-0166-2016 |
| Recalling firm | Perkin Elmer Life Sciences Inc |
| Product type | Devices |
| Products | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 24, 2015 |
| Report date | Nov 4, 2015 |
| Termination date | Jan 21, 2021 |
| City | Turku |
| Country | Finland |
| FEI number | 3007112263 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: