Recall Z-2114-2020 ยท CEM Electrode, Ion Specific, Potassium
Inpeco S.A.
FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-2
| Date | Apr 7, 2020 |
| Status | Terminated |
| Reason | The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design. |
| Root cause | Component design/selection |
| Action | Urgent: Medical Device Correction notification letters dated 3/30/20 were sent to customers. Action to be taken by the user After module protection removal, wait at least 2 seconds before accessing the impacted module (listed in Table 1). Your service provider will contact you to replace the sensor. Until the service visit please maintain awareness on this notice. Please complete and return the "Customer Letter Receipt Confirmation and Implementation Check form" attached to this letter within 15 days directly to the email address specified in the email communication. Please transfer this |
| Quantity | 10 systems |
| Distribution | The products were distributed to the following US States: IL and NY. |
| 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 |