Recall Z-0361-2019 ยท JQP Calculator/Data Processing Module, For Clinical Use
Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
| Date | Aug 24, 2018 |
| Status | Terminated |
| Reason | The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has been increased to 200 mm (7.87") from the transport mechanisms. Any person with a pacemaker must not get closer than this distance from the modules axes. |
| Root cause | Under Investigation by firm |
| Action | On 8/24/18, the firm, Inpeco, notified distributors of the recall via an "Urgent IVD Medical Device Recall" letter dated August 2018. Distributors were informed of the product issue and instructed to further notify end users. Advise on action to be taken by the user: 1. Please be aware that personnel fitted with a pacemaker must not handle or work on these modules at distances lower than 200 mm even if the warning label is missing. 2. Please review the attached OM Errata Sheet and save it with the Operations Manual you currently have available for future references regarding the "safety dista |
| Quantity | 679 |
| Distribution | Foreign distribution to Netherlands, Italy, Belgium, Austria, France, Spain, and Germany. |
| 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 |