Drug recall
Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and…
FDA recall event 76165 · Class II · PerkinElmer Life and Analytical Sciences, Wallac, OY
Key facts
| Event ID | 76165 |
|---|---|
| Recall numbers | Z-1107-2017, Z-1108-2017 |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY |
| Product type | Devices |
| Products | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids., Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the… |
| Initiation date | Jan 5, 2017 |
| Report date | Feb 8, 2017 |
| Termination date | Aug 24, 2017 |
| 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: