CLASS II ONGOING Device recall · Reported 10 Jun 2020 · FDA Enforcement Report
FlexLab Augomation System using the Aliquoter Module (Inpeco recalled
Inpeco is recalling FlexLab Augomation 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-2198-2020
- 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
Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. 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
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) 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?
Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. 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: FLX.008 FLX.0105 FLX.0106 FLX.0107 FLX.0113 FLX.0114 FLX.0115 FLX.0116 FLX.0118 FLX.0119 FLX.012 FLX.0121 FLX.0124 FLX.0125 FLX.0126 FLX.0127 FLX.0128 FLX.0129 FLX.0131 FLX.0135 FLX.0136 FLX.0138 FLX.014 FLX.0140 FLX.0141 FLX.0143 FLX.015 FLX.0152 FLX.0155 FLX.0158 FLX.0161 FLX.0164 FLX.017 FLX.018 FLX.0196 FLX.020 FLX.021 FLX.022 FLX.023 FLX.027 FLX.029 FLX.030 FLX.031 FLX.032 FLX.033 FLX.037 FLX.038 FLX.039 FLX.043 FLX.044 FLX.046 FLX.047 FLX.050 FLX.051 FLX.052 FLX.056 FLX.060 FLX.064 FLX.071 FLX.072 FLX.074 FLX.075 FLX.076 FLX.077 FLX.080 FLX.082 FLX.083 FLX.093 FLX.101 FLX.102 TSH.003
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 85469This product is part of a recall event; the main page for the event is Accelerator a3600 Automation System using the Aliquoter recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Accelerator a3600 Automation System using the Aliquoter recalled | Inpeco | Other | Nationwide | |
| CLASS II | Aptio Automation 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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