Class 2 Device Recall Inpeco SA FlexLab, Accelerator a3600 and Aptio Automation

• Date Initiated by Firm: October 04, 2016
• Create Date: November 16, 2016
• Recall Status: Terminated on May 31, 2019
• Recall Number: Z-0587-2017
• Recall Event ID: 75513
• 510(K)Number: K121012
• Product Classification: Electrode, ion specific, potassium - Product Code CEM
• Product: FlexLab, Accelerator a3600 and Aptio Automation are modular systems 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: Shucko Socket with P/N: 693822160, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 3 meters; Shucko Socket with P/N: 693822170, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 5 meters; Shucko Socket with P/N: 693822190, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 7 meters; Shucko Socket with P/N: 0C00005640, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 2 meters. The Serial number of the impacted products globally distributed are the following: ACP.009, ACP.024, ACP.039, ACP.054, ACP.069, ACP.084, ACP.100, ACP.115 , ACP.010, ACP.025, ACP.040, ACP.055, ACP.070, ACP.085, ACP.101, ACP.116, ACP.011, ACP.026, ACP.041, ACP.056, ACP.071, ACP.086, ACP.102, ACP.117, ACP.012, ACP.027, ACP.042, ACP.057, ACP.072,ACP.087, ACP.103, ACP.118 , ACP.013, ACP.028, ACP.043, ACP.058, ACP.073, ACP.088, ACP.104, ACP.119, ACP.014, ACP.029, ACP.044, ACP.059, ACP.074, ACP.089, ACP.105, ACP.120, ACP.015, ACP.030, ACP.045, ACP.060, ACP.075, ACP.090, ACP.110, ACP.121, ACP.016, ACP.031, ACP.046, ACP.061, ACP.076, ACP.091, ACP.107, ACP.122 ,ACP.017, ACP.032, ACP.047, ACP.062, ACP.077, ACP.092, ACP.108, ACP.123 ,ACP.018, ACP.033, ACP.048, ACP.063, ACP.078, ACP.093, ACP.109, ACP.124, ACP.019, ACP.034, ACP.049, ACP.064, ACP.079, ACP.094, ACP.110, ACP.125, ACP.020, ACP.035, ACP.050, ACP.065, ACP.080, ACP.096, ACP.111, ACP.126 ,ACP.021, ACP.036, ACP.051, ACP.066, ACP.081, ACP.097, ACP.112, ACP.127 , ACP.022, ACP.037, ACP.052, ACP.067, ACP.082, ACP.098, ACP.113, ACP.128, ACP.023, ACP.038, ACP.053, ACP.068, ACP.083, ACP.099, ACP.114, ACP.129, FLX.103, FLX.0120, FLX.0131, FLX.0137, FLX.0143, FLX.0161, FLX.0166, FLX.0179, FLX.0104, FLX.0124, FLX.0134, FLX.0140, FLX.0152, FLX.0163, FLX.0175, FLX.0108, FLX.0125, FLX.0135, FLX.0141 FLX.0155, FLX.0164, FLX.0176, FLX.0115, FLX.0126, FLX.0136, FLX.0142, FLX.0158, FLX.0165, FLX.0178, AP2.0001, AP2.0004, AP2.0006, AP2.0008, AP2.0010, AP2.0012, AP2.0014, AP2.0003, AP2.0002, AP2.0005, AP2.0007, AP2.0009, AP2.0011, AP2.0013, AP2.0015, FLX.0008, FLX.0133, FLX.0149, FLX.0153, FLX.0159, FLX.0167, FLX.0170, FLX.0174, FLX.0069, FLX.0139, FLX.0150 FLX.0156, FLX.0162, FLX.0168, FLX.0172, FLX.0179, FLX.0132, FLX.0147, FLX.0151, FLX.0157, FLX.0166, FLX.0169, FLX.0173 ,FLX.0121, FLX.0138, FLX.0144, FLX.0145, FLX.0146, FLX.0148, FLX.0176 and FLX.0181.
• Recalling Firm/ Manufacturer: Inpeco S.A.; Via San Gottardo 10; Lugano Switzerland
• Manufacturer Reason for Recall: Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets.
• FDA Determined Cause: Employee error
• Action: Inpeco sent an Urgent Field Safety Notice dated October 2016 for the Aptio Automation, the Accelerator a3600 and the FlexLab Shucko power cord cables to all affected US and foreign customers. The Urgent Field Safety Notice described the reason for the recalls and actions that should be taken. The firm is requesting all customers to complete and return the Field Correction Effectiveness Check form attached to the Urgent Field Safety Notice letter within 7 days. The Urgent Field Safety Notice letter should be forwarded to affected departments or consignees. To mitigate any possible risks to the laboratory users' health conditions due to the defective power cords Inpeco released a Technical Service Bulletin (TSB) addressed only to Field Service Engineer with the procedure which has to be performed in order to prevent other cases of damaged sockets. The FSE has to check visually the appearance of the Schuko female socket. If it is intact, without any detectable deformation nor melting the FSE has to verify that the terminals are correctly crimped into each single wire. If the female socket presents alterations, the socket has to be replaced with a new one. The affected sockets will be destroyed. Customers with questions were instructed to call (+41) 91 9118 258.
• Quantity in Commerce: 188 units
• Distribution: Worldwide Distribution - US including Texas and New York. Foreign Consignees: Germany, Italy, France, Austria and Spain.
• 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