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 identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube. |
| Product | Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. |
| Quantity | 70 systems |
| Distribution | US Nationwide including in the states of IL, NY. |
| Initiated | 2020-04-07 |
| Classified | 2020-05-28 |
| Terminated | 2024-02-06 |
| Recall number | Z-2142-2020 |
| 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-2142-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85444/
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