Recall Z-1798-2018 ยท JQP Calculator/Data Processing Module, For Clinical Use
Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
| Date | Feb 13, 2018 |
| Status | Terminated |
| Reason | Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients. |
| Root cause | Device Design |
| Action | On 2/13/18, distributors were notified by emailed Technical Service Bulletin. The recalling firm also released a Customer Letter to be forwarded to final customers (labs) by distributors. The Customer Letter advised users of the issue and informed that the recalling firm would be visiting sites to upgrade the firmware to resolve the issue. All impacted customers were instructed to complete and return the Receipt Confirmation within 7 days. Contact provided: Giorgia Amabile - Quality Assurance & Regulatory Affairs Manager, giorgia.amabile@inpeco.com, (+41) 91 9118 258. |
| Quantity | 18 |
| Distribution | Distributors in 2 states: NY and IL. |
| 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 |