Drug recall
Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271…
FDA recall event 85537 · Class II · Inpeco S.A.
Key facts
| Event ID | 85537 |
|---|---|
| Recall numbers | Z-2114-2020, Z-2115-2020 |
| Recalling firm | Inpeco S.A. |
| Product type | Devices |
| Products | Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N…, FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by… |
| Initiation date | Apr 7, 2020 |
| Report date | Jun 3, 2020 |
| Termination date | Jun 13, 2024 |
| City | Lugano |
| Country | Switzerland |
| FEI number | 3010825766 |
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: