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U.S. Department of Health and Human Services

Class 2 Device Recall Inpeco SA

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  Class 2 Device Recall Inpeco SA see related information
Date Initiated by Firm April 07, 2020
Create Date May 14, 2020
Recall Status1 Terminated 3 on July 28, 2022
Recall Number Z-2004-2020
Recall Event ID 85454
510(K)Number K121012  
Product Classification Electrode, ion specific, potassium - Product Code CEM
Product Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) 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: ACP.001, ACP.002, ACP.003, ACP.004, ACP.007, ACP.008, ACP.010, ACP.011, ACP.013, ACP.014, ACP.015, ACP.016, ACP.017, ACP.018, ACP.019, ACP.020, ACP.022, ACP.023, ACP.024, ACP.025, ACP.026, ACP.027, ACP.028, ACP.029, ACP.030, ACP.031, ACP.032, ACP.033, ACP.034, ACP.035, ACP.036, ACP.038, ACP.041, ACP.042, ACP.043, ACP.044, ACP.045, ACP.046, ACP.047, ACP.048, ACP.049, ACP.050, ACP.051, ACP.052, ACP.053, ACP.055, ACP.056, ACP.057, ACP.058, ACP.059, ACP.060, ACP.061, ACP.063, ACP.064, ACP.066, ACP.067, ACP.068, ACP.069, ACP.070, ACP.071, ACP.072, ACP.073, ACP.074, ACP.075, ACP.076, ACP.078, ACP.079, ACP.080, ACP.081, ACP.082, ACP.084, ACP.085, ACP.086, ACP.088, ACP.090, ACP.092, ACP.093, ACP.094, ACP.096, ACP.098, ACP.099, ACP.100, ACP.101, ACP.102, ACP.103, ACP.104, ACP.105, ACP.106, ACP.109, ACP.110, ACP.111, ACP.113, ACP.114, ACP.115, ACP.116, ACP.117, ACP.118, ACP.119, ACP.120, ACP.121, ACP.122, ACP.123, ACP.124, ACP.125, ACP.127, ACP.128, ACP.129, ACP.130, ACP.131, ACP.132, ACP.133, ACP.134, ACP.135, ACP.137, ACP.138, ACP.139, ACP.140, ACP.141, ACP.142, ACP.143, ACP.145, ACP.146, ACP.147, ACP.148, ACP.149, ACP.151, ACP.152, ACP.154, ACP.155, ACP.156, ACP.157, ACP.158, ACP.159, ACP.160, ACP.161, ACP.162, ACP.163, ACP.164, ACP.165, ACP.166, ACP.167, ACP.168, ACP.169, ACP.170, ACP.171, ACP.172, ACP.173, ACP.174, ACP.175, ACP.176, ACP.177, ACP.178, ACP.181, ACP.182, ACP.190, ACP.191, ACP.193, ACP.195, ACP.196, ACP.197, ACP.198, ACP.199, ACP.200, ACP.201, ACP.203, ACP.204, ACP.205, ACP.206, ACP.207, ACP.209, ACP.210, ACP.211, ACP.212, ACP.213, ACP.215, ACP.216, ACP.217, ACP.218, ACP.219, ACP.220, ACP.221, ACP.222, ACP.223, ACP.224, ACP.225, ACP.227, ACP.228, ACP.229, ACP.231, ACP.232, ACP.234, ACP.236, ACP.237, ACP.239, ACP.240, ACP.241, ACP.242, ACP.243, ACP.244, ACP.245, ACP.246, ACP.247, ACP.254, ACP.255, ACP.257, ACP.259, ACP.260, ACP.261, ACP.265, ACP.267, ACP.272, ACP.276, ACP.278, ACP.279, ACP.280, ACP.281, ACP.283, ACP.285, ACP.287, ACP.289, ACP.292, ACP.293, ACP.294, ACP.299, ACP.300, ACP.301, ACP.303, ACP.304, ACP.306, ACP.307, ACP.308, ACP.309, ACP.316, ACP.317, ACP.319, ACP.320, ACP.321, ACP.322, ACP.324, ACP.325, ACP.326, ACP.327, ACP.329, ACP.332, ACP.333, ACP.337, ACP.341, ACP.342, ACP.345, ACP.346, ACP.347, ACP.350, ACP.351, ACP.352, ACP.359, ACP.374, ACP.377, ACP.383, ACP.390, ACP.391, ACP.392, ACP.402, ACP.404, ACP.411, ACP.412, ACP.416, ACP.421, ACP.422, ACP.428, ACP.430, ACP.434, ACP.441, ACP.442 
Recalling Firm/
Manufacturer		 Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
For Additional Information Contact Ms. Eva Balzarotti
41-919118200
Manufacturer Reason
for Recall		 When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
FDA Determined
Cause 2		 Software design
Action On April 7, 2020, the firm sent an Urgent Medical Device Correction letter to all impacted customers and instructed them to return the Customer Letter Receipt Confirmation and Implementation Check form within 15 days. The customers were asked to confirm that they had read, understood, and applied all the applicable recommended actions. The impacted Customers were told that they would be contacted by their service representative to schedule the system update.
Quantity in Commerce 273
Distribution Worldwide distribution - US Nationwide including in the states of Texas, West Virginia, South Carolina, Delaware, Louisiana, Illinois, Georgia, Florida, New York, Virginia, Arkansas, Wisconsin, California, Minnesota, Missouri, North Carolina, Utah, Michigan, Ohio, Alabama, Oklahoma, Tennessee, Kansas, Hawaii, Arizona, Washington
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 = CEM and Original Applicant = INPECO S.P.A.
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