| Date Initiated by Firm |
April 07, 2020 |
| Create Date |
May 28, 2020 |
| Recall Status1 |
Terminated 3 on February 06, 2024 |
| Recall Number |
Z-2140-2020 |
| Recall Event ID |
85444 |
| 510(K)Number |
K121012
|
| Product Classification |
Calculator/data processing module, for clinical use - Product Code JQP
|
| Product |
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. |
| Code Information |
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 |
Recalling Firm/
Manufacturer |
Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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.
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 |
| Quantity in Commerce |
37 systems |
| Distribution |
US Nationwide including in the states of IL, NY. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = JQP and Original Applicant = INPECO S.P.A.
|
