FlexLab Automation System with Advia2120LAS Interface Module — Class II medical device recall Z-2140-2020
Terminated recall by Inpeco S.A., reported 2020-06-03, distributed nationwide. The identified problem is an erroneous association between the carrier and the sample tube caused by a communi
| Recall number | Z-2140-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inpeco S.A., Lugano, N/A, Switzerland |
| Recall initiated | 2020-04-07 |
| Classified | 2020-05-28 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2024-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 37 systems |
| Reason classes | software |
| Serial numbers | FLX.005, FLX.006, FLX.011, FLX.0117, FLX.0121, FLX.0124, FLX.0126, FLX.0129, FLX.0133, FLX.0136, FLX.0139, FLX.0140, FLX.0147, FLX.0149, FLX.0153, FLX.0157, FLX.016, FLX.0165, FLX.0168, FLX.0173, FLX.0189, FLX.0191, FLX.0192, FLX.022, FLX.030 and 12 more |
Product
FlexLab 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)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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2140-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.