FDA Device recall Z-0433-2021
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation)…
- FDA Device
- Class II
- terminated
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation)… by Inpeco, citing when a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. Th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0433-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-14 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Inpeco |
| Distribution | n/a |
Product
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) 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
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
Identifiers
| code_info | The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware versions listed below or…The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware versions listed below or higher: - AQMb_3-3-0.H86 - AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86 - xAQMb_1-1-0.elf; System Serial Numbers: ACP.048 ACP.142 ACP.194 ACP.113 ACP.104 ACP.244 ACP.252 ACP.253 ACP.268 ACP.290 ACP.363 ACP.181 ACP.009 ACP.015 ACP.027 ACP.042 ACP.092 ACP.432 ACP.303 ACP.004 ACP.011 ACP.028 ACP.093 ACP.163 ACP.226 ACP.275 ACP.267 ACP.276 ACP.329 ACP.033 ACP.012 ACP.235 ACP.064 ACP.164 ACP.209 ACP.217 ACP.263 ACP.295 ACP.297 ACP.323 ACP.396 ACP.410 ACP.115 ACP.214 ACP.331 ACP.243 ACP.259 ACP.085 ACP.141 ACP.237 ACP.172 ACP.218 ACP.257 ACP.280 ACP.336 ACP.364 ACP.298 ACP.337 ACP.066 ACP.088 ACP.123 ACP.248 ACP.182 ACP.442 ACP.291 ACP.026 ACP.047 ACP.171 ACP.265 ACP.426 ACP.018 ACP.286 ACP.102 ACP.063 ACP.076 ACP.230 ACP.233 ACP.258 ACP.334 ACP.360 ACP.378 ACP.391 ACP.437 ACP.250 ACP.314 A |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0433-2021%22
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