Recall Z-2141-2020 ยท JQP Calculator/Data Processing Module, For Clinical Use
Inpeco S.A.
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multi
| Date | Apr 7, 2020 |
| Status | Terminated |
| Reason | The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube. |
| Root cause | Software design |
| Action | Urgent: Medical Device Correction notification letters dated 3/30/20 were sent to customers. 1) Visually check that the secondary lane of the Interface Modules listed in Table 1 is empty before sending the Off-line command; or 2) Select the "Going to Off-line" command for the Interface Modules listed in Table 1. This ensures that the Module completes processing samples already inside the Module, releases the tubes and then passes to Off-line status. Your service provider will contact you to schedule the firmware upgrade. Until the service visit please maintain awareness on this notice. Plea |
| Quantity | 3 systems |
| Distribution | US Nationwide including in the states of IL, 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 |