Drug recall
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software…
FDA recall event 79421 · Class II · PerkinElmer Life and Analytical Sciences, Wallac, OY
Key facts
| Event ID | 79421 |
|---|---|
| Recall numbers | Z-1541-2018 |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results. |
| Initiation date | Nov 17, 2017 |
| Report date | May 9, 2018 |
| Termination date | Aug 12, 2021 |
| City | Turku |
| Country | Finland |
| FEI number | 3002808498 |
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: