Accelerator a3600 Automation System using the Aliquoter Module — Class II medical device recall Z-2199-2020
Ongoing recall by Inpeco S.A., reported 2020-06-10, distributed nationwide. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the
| Recall number | Z-2199-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inpeco S.A., Lugano, N/A, Switzerland |
| Recall initiated | 2020-04-07 |
| Classified | 2020-06-01 |
| Reported by FDA | 2020-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 97 systems |
| Reason classes | software |
| Serial numbers | ACP.002, ACP.004, ACP.009, ACP.011, ACP.012, ACP.015, ACP.018, ACP.019, ACP.026, ACP.027, ACP.028, ACP.033, ACP.034, ACP.042, ACP.045, ACP.047, ACP.048, ACP.050, ACP.052, ACP.059, ACP.061, ACP.063, ACP.064, ACP.066, ACP.069 and 72 more |
Product
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
Reason for recall
In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
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-2199-2020. 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.