Recall Z-0087-2022 ยท CEM Electrode, Ion Specific, Potassium
Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
| Date | Sep 10, 2021 |
| Status | Open, Classified |
| Reason | The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result. |
| Root cause | Software design |
| Action | On September 10, 2021, the firm distributed "Urgent IVD Medical Device Correction" letters to affected consignees. Distributors were instructed to forward the recall communication to downstream customers. Customers were informed that the potential risk associated with the issue is related to an incorrect patient result that may lead to incorrect patient treatment. Users were provided with detailed instructions on precautions to avoid the occurrence of the described issue, including a daily visual check and what to do in case of error 3160 or 0D60. Contact your local technical support provid |
| Quantity | 262 total, 52 US |
| Distribution | Domestic distribution nationwide . Foreign distribution worldwide. |
| 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 |