Recall Z-2200-2020 ยท CEM Electrode, Ion Specific, Potassium
Inpeco S.A.
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
| Date | Apr 7, 2020 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | Urgent: Medical Device Correction dated 03/30/2020 were sent to customers. The impacted modules are the Aliquoter Modules (Inpeco Part Number FLX-212) with a firmware version prior to the following: AQMb_3-3-0.H86; AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86; xAQMb_1-1-0.elf; Action to be taken by the user To avoid the risk of contamination take the following precaution: 1) Discard the Primary Tube flagged with Clot Detection error or manage it according to your laboratory guidelines considering that it may be diluted. 2) Call Service Assistant in case the frequency of the Clot Detection Error i |
| Quantity | 61 systems |
| Distribution | US Nationwide distribution including in the states of IL, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121012 | FLEXLAB 3.6, ACCELERATOR A3600 Inpeco S.P.A., Aug 31, 2012 |