Abbott Accelerator a3600 — Class II medical device recall Z-2004-2020
Terminated recall by Inpeco S.A., reported 2020-05-20, distributed nationwide. When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors cou
| Recall number | Z-2004-2020 |
|---|---|
| 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 | 2020-05-14 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2022-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 273 |
| Serial numbers | ACP.001, ACP.002, ACP.003, ACP.004, ACP.007, ACP.008, ACP.010, ACP.011, ACP.013, ACP.014, ACP.015, ACP.016, ACP.017, ACP.018, ACP.019, ACP.020, ACP.022, ACP.023, ACP.024, ACP.025, ACP.026, ACP.027, ACP.028, ACP.029, ACP.030 and 248 more |
| Model numbers | ACP-208-00 |
Product
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) 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
When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
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-2004-2020. 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.