Inpeco S.A. voluntarily recalled three Accelerator a3600 Automation Systems on April 7, 2020, according to the FDA. The recall addresses a communication error that can cause erroneous sample associations. The agency announced the Class II device recall.
How to tell if you have it
- Brand: Inpeco
- Product: Accelerator a3600 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)
- Serial Numbers: ACP.290, ACP.343, ACP.365
- Units affected: 3 systems
The hazard
The hazard 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 occurs 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.
Context
GovInfoNow's records show Inpeco S.A. has 13 other recalls on record since 2025-10-30. Other recent recalls of similar products include Inpeco FlexLab FLX-217-40 (2025-10-30), Inpeco FlexLab X Potassium Test System (2025-09-03), and Roche Cobas 8000 Interface Module (2023-11-03).