| Date Initiated by Firm |
April 07, 2020 |
| Create Date |
May 28, 2020 |
| Recall Status1 |
Terminated 3 on February 06, 2024 |
| Recall Number |
Z-2142-2020 |
| Recall Event ID |
85444 |
| 510(K)Number |
K121012
|
| Product Classification |
Calculator/data processing module, for clinical use - Product Code JQP
|
| Product |
Aptio 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) - Product Usage: 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: AP2.0003 AP2.0007 AP2.0008 AP2.0009 AP2.0010 AP2.0017 AP2.0022 AP2.0025 AP2.0036 AP2.0049 AP2.0052 AP2.0057 AP2.0058 AP2.0059 AP2.0064 AP2.0065 AP2.0077 AP2.0082 AP2.0083 AP2.0089 AP2.0090 AP2.0092 AP2.0098 AP2.0100 AP2.0105 AP2.0109 AP2.0110 AP2.0129 AP2.0136 AP2.0149 AP2.0156 AP2.0173 AP2.0179 AP2.0180 AP2.0181 AP2.0193 AP2.0194 AP2.0201 AP2.0202 AP2.0211 AP2.0230 AP2.0233 AP2.0235 AP2.0236 AP2.0238 AP2.0251 AP2.0254 AP2.0258 AP2.0264 AP2.0269 AP2.0270 AP2.0275 AP2.0289 AP2.0295 AP2.0317 AP2.0325 AP2.0332 AP2.0339 AP2.0375 AP2.0381 AP2.0394 AP2.0411 AP2.0427 APT.0009 APT.0014 APT.0058 APT.0065 APT.0091 APT.0136 APT.0247 |
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 |
70 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.
|
