CLASS II ONGOING Device recall · Reported 10 Jun 2020 · FDA Enforcement Report
Aptio Automation System using the Aliquoter Module (Inpeco recalled
Inpeco is recalling Aptio 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-2200-2020
- 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
- Lead & Heavy Metals
- 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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Aptio 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
Is Aptio Automation System using the Aliquoter Module (Inpeco recalled?
Yes. Inpeco recalled Aptio Automation System using the Aliquoter Module (Inpeco on 7 Apr 2020. The recall is Class II and its status is Ongoing. Recall number Z-2200-2020.
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: AP2.0005 AP2.0008 AP2.0010 AP2.0014 AP2.0017 AP2.0018 AP2.0022 AP2.0023 AP2.0026 AP2.0027 AP2.0033 AP2.0036 AP2.0039 AP2.0043 AP2.0045 AP2.0056 AP2.0060 AP2.0065 AP2.0069 AP2.0070 AP2.0071 AP2.0076 AP2.0078 AP2.0081 AP2.0087 AP2.0089 AP2.0102 AP2.0104 AP2.0105 AP2.0110 AP2.0111 AP2.0113 AP2.0120 AP2.0127 AP2.0137 AP2.0139 AP2.0146 AP2.0147 AP2.0149 AP2.0151 AP2.0155 AP2.0165 AP2.0170 AP2.0172 AP2.0184 AP2.0189 AP2.0201 AP2.0202 AP2.0203 AP2.0209 AP2.0211 AP2.0213 AP2.0217 AP2.0223 APT.0009 APT.0014 APT.0058 APT.0065 APT.0093 APT.0091 APT.0125
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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