CLASS II ONGOING Device recall · Reported 10 Jun 2020 · FDA Enforcement Report
Accelerator a3600 Automation System using the Aliquoter recalled
Inpeco is recalling Accelerator a3600 Automation System using the Aliquoter Module (Inpeco, distributed nationwide in the US. The recall was initiated on 7 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2199-2020
- FDA event ID
- 85469
- Recalling firm
- Inpeco, Lugano, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Apr 2020
- FDA classified
- 1 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Apr 2020 | Recall initiated by company | |
| 1 Jun 2020 | Classified by FDA | +55 days |
| 10 Jun 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the states of IL, NY.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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 ACP.070 ACP.071 ACP.073 ACP.076 ACP.085 ACP.088 ACP.092 ACP.093 ACP.101 ACP.102 ACP.104 ACP.113 ACP.119 ACP.120 ACP.123 ACP.131 ACP.141 ACP.142 ACP.146 ACP.163 ACP.164 ACP.171 ACP.172 ACP.182 ACP.185 ACP.186 ACP.194 ACP.205 ACP.209 ACP.214 ACP.217 ACP.218 ACP.226 ACP.229 ACP.230 ACP.232 ACP.233 ACP.235 ACP.236 ACP.237 ACP.242 ACP.243 ACP.244 ACP.248 ACP.250 ACP.252 ACP.253 ACP.257 ACP.258 ACP.259 ACP.263 ACP.265 ACP.267 ACP.268 ACP.275 ACP.276 ACP.280 ACP.286 ACP.289 ACP.290 ACP.291 ACP.294 ACP.295 ACP.297 ACP.298 ACP.299 ACP.303 ACP.304 ACP.314 ACP.323 ACP.332 ACP.336
Where was it sold?
US Nationwide distribution including in the states of IL, NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 85469| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Aptio Automation System using the Aliquoter Module (Inpeco recalled | Inpeco | Other | Nationwide | |
| CLASS II | FlexLab Augomation System using the Aliquoter Module (Inpeco recalled | Inpeco | Other | Nationwide |
More recalls from Inpeco
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FlexLab (FLX) recalled by Inpeco | Inpeco | Other | MI |
| Device | CLASS II | FlexLab (FLX) recalled by Inpeco | Inpeco | Other | MI |
| Device | CLASS II | FlexLab (FLX) System recalled by Inpeco | Inpeco | Other | CA, NY |
| Device | CLASS II | FlexLab X (FXX) System recalled by Inpeco | Inpeco | Other | CA, NY |
| Device | CLASS II | Roche Cobas 8000 and Cobas PRO Interface Module recalled by Inpeco | Inpeco | Other | Nationwide |
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