FlexLab 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 multiple Analytical instruments into a unified workstation.
- Recall Initiated
- April 7, 2020
- Terminated
- February 6, 2024
- Recall Number
- Z-2140-2020
- Quantity
- 37 systems
Reason for Recall
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.
Distribution
US Nationwide including in the states of IL, NY.
Lot / Code Info
Serial Numbers: FLX.005 FLX.006 FLX.011 FLX.0117 FLX.0121 FLX.0124 FLX.0126 FLX.0129 FLX.0133 FLX.0136 FLX.0139 FLX.0140 FLX.0147 FLX.0149 FLX.0153 FLX.0157 FLX.016 FLX.0165 FLX.0168 FLX.0173 FLX.0189 FLX.0191 FLX.0192 FLX.022 FLX.030 FLX.032 FLX.035 FLX.036 FLX.037 FLX.050 FLX.056 FLX.060 FLX.062 FLX.065 FLX.082 FLX.096 SHD.002
Root Cause
Software design
Action Taken
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. 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 notice to whom it might concern. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-mail: Regulatory.Affairs@inpeco.com Phone: (+41) 919118 224