Drug recall
Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser…
FDA recall event 80115 · Class II · Zeiss, Carl Inc
Key facts
| Event ID | 80115 |
|---|---|
| Recall numbers | Z-2058-2018 |
| Recalling firm | Zeiss, Carl Inc |
| Product type | Devices |
| Products | Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA Requested |
| Reason for recall | In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit. |
| Initiation date | May 8, 2018 |
| Report date | Jun 20, 2018 |
| Termination date | Apr 21, 2020 |
| City | Thornwood |
| State | NY |
| Country | United States |
| FEI number | 2431026 |
At a glance
- 1–9 Products in this recall
- 1–9 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: