Recall Z-1562-2023 ยท CEM Electrode, Ion Specific, Potassium
Inpeco S.A.
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
| Date | May 4, 2023 (initiated Mar 10, 2023) |
| Status | Open, Classified |
| Reason | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead t |
| Root cause | Under Investigation by firm |
| Action | Impeco issued Urgent: Medical Device Correction Letter for affected product: Flexlab/Accelerator a3600/Aptio Automation on 3/10/23 to US Distributors and Direct End Users via email. Letter states reason for recall, health risk and action to take: The scenario occurs in the case of a divert malfunction .. To avoid the occurrence of the described issue lnpeco recommends to visually check every day the gates at the buffer lane entry of the impacted modules (refer to Image l.a and Image l.b) to verify that: there are no obstructions that prevent the correct activation and movement of the divert; t |
| Quantity | US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems). |
| Distribution | Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NO |
| 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 |