Recall Z-0560-2024 ยท CEM Electrode, Ion Specific, Potassium
Inpeco S.A.
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0
| Date | Dec 15, 2023 (initiated Nov 3, 2023) |
| Status | Open, Classified |
| Reason | Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing. |
| Root cause | Software Design Change |
| Action | Inpeco issued Urgent Medical Device Correction Letter (Recall-identifier: 3010825766 11/06/23 002 C) via email on 11/3/23. Letter states reason for recall, health risk and action to take: Please apply the following instructions to detect the sample tubes potentially impacted by the issue (Step 1) and to manage them according to the specific occurred scenario (Step 2). If Step 1 leads to determine that the issue has not occurred, Step 2 is not to be performed. Note: The test orders status displayed on the IUI is not overwritten neither changed in any way due to the issue: it would be po |
| Quantity | 1 unit US: 14 units OUS |
| Distribution | Worldwide - US Nationwide distribution in the state of MA and the countries of AUSTRIA, BELGIUM, DENMARK, ITALY, NORWAY, SPAIN. |
| 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 |