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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) see related information
Date Initiated by Firm February 13, 2018
Create Date May 10, 2018
Recall Status1 Terminated 3 on April 03, 2019
Recall Number Z-1798-2018
Recall Event ID 79645
510(K)Number K121012  
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Code Information Serial Numbers:  Accelerator a3600 -  ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214  FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181  Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095  Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers
Recalling Firm/
Manufacturer		 Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
Manufacturer Reason
for Recall		 Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
FDA Determined
Cause 2		 Device Design
Action On 2/13/18, distributors were notified by emailed Technical Service Bulletin. The recalling firm also released a Customer Letter to be forwarded to final customers (labs) by distributors. The Customer Letter advised users of the issue and informed that the recalling firm would be visiting sites to upgrade the firmware to resolve the issue. All impacted customers were instructed to complete and return the Receipt Confirmation within 7 days. Contact provided: Giorgia Amabile - Quality Assurance & Regulatory Affairs Manager, giorgia.amabile@inpeco.com, (+41) 91 9118 258.
Quantity in Commerce 18
Distribution Distributors in 2 states: NY and IL.
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.
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