Class II — Inpeco S.A.
| Recalling firm | Inpeco SA |
|---|---|
| Registered facility | INPECO SA (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 design. |
| Product | 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 FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical pro… |
| Quantity | 2 systems |
| Distribution | The products were distributed to the following US States: IL and NY. |
| Initiated | 2020-04-07 |
| Classified | 2020-05-26 |
| Terminated | 2024-06-13 |
| Recall number | Z-2115-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Inpeco S.A. (Z-2115-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85537/
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