Class 2 Device Recall FlexLab (FLX), Accelerator a3600 (ACP), and Aptio Automation (AP2)

• Date Initiated by Firm: March 10, 2023
• Date Posted: May 04, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1562-2023
• Recall Event ID: 91950
• 510(K)Number: K121012
• Product Classification: Electrode, ion specific, potassium - Product Code CEM
• Product: Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system; ; Brand names of the same product: FlexLab (FLX), Accelerator; a3600 (ACP), Aptio Automation (AP2); ; Part Numbers: 72747000.A
• Code Information: UDI: FlexLab 07640172340004 Accelerator a3600 07640172341001 Aptio¿ Automation 07640172342008 Firmware Versions: All versions
• Recalling Firm/ Manufacturer: Inpeco S.A.; Via San Gottardo 10; Lugano Switzerland
• Manufacturer Reason for Recall: Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the test orders not performed yet on Tube B. Inpeco has released a Technical Service Bulletin with the procedure to correctly update the firmware. The firmware upgrade will be performed by Field Service Engineers. A CAPA (Corrective Action Preventive Action) has been opened to deeply investigate the root cause and identify possible process lack in order to avoid reoccurrences.
• FDA Determined Cause: Under Investigation by firm
• Action: Impeco issued Urgent: Medical Device Correction Letter for affected product: Flexlab/Accelerator a3600/Aptio Automation on 3/10/23 to US Distributors and Direct End Users via email. Letter states reason for recall, health risk and action to take: The scenario occurs in the case of a divert malfunction .. To avoid the occurrence of the described issue lnpeco recommends to visually check every day the gates at the buffer lane entry of the impacted modules (refer to Image l.a and Image l.b) to verify that: there are no obstructions that prevent the correct activation and movement of the divert; the divert looks to be intact, refer to Image 2.a and Image 2.b; the position of the divert is aligned to the profiles when it is diverting a tube, refer to Image 3.a and Image 3.b; tubes that need to be routed by the module are diverted fluidly, without any missing or partial block of the carrier. If the visual check is not passed, contact your local technical support for assistance before using the Automation System impacted modules to process samples. Your service provider will contact you to schedule the firmware upgrade. Until the service visit please maintain awareness on this notice and apply the actions recommended above. Please transfer this notice to whom it might concern. Please complete and return the "Customer Letter Receipt Confirmation and Implementation Check" form attached to this letter within 30 days directly to the email address specified in the email communication. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-maii:Eva.Balzarotti@inpeco.com Phone: (+41) 91 9118 224
• Quantity in Commerce: US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
• Distribution: Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UK, VIETNAM.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CEM and Original Applicant = INPECO S.P.A.