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,

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.

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 distance" required for pacemakers. 3. Please verify that the modules listed in Table 1 have the pacemaker safety label attached. If the safety pacemaker label is missing, please remove the last page of this letter and tape the copy of the label on the cover of these modules until the official label is available. If your site is included in the list of Systems where at least one pacemaker label is missing, lnpeco Service or their representatives will contact you to arrange a visit to address the described problem and apply the missing labels. In addition: " complete and return the Field Safety Notice Receipt Confirmation form attached to this letter within 15 days directly to lnpeco or to lnpeco representative. If you have any questions or concerns regarding this recall, please contact Giorgia Amabile, Quality and Regulatory Manager, at [email protected], or (+41) 91-9118-258.