Recall Z-1887-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Inpeco S.A.
Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
| Date | Apr 7, 2020 |
| Status | Open, Classified |
| Reason | The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge. |
| Root cause | Software design (manufacturing process) |
| Action | The firm sent an Urgent Medical Device Correction letter to all affected customers on March 30, 2020. The letter instructed the customers to complete and return the Customer Letter Receipt Confirmation and Implementation Check form. The firm explained that their regular service provider will contact them to schedule the firmware version upgrade. |
| Quantity | 65 units |
| Distribution | Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan |
| 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 |