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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 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-1888-2020
Recall Event ID 85429
510(K)Number K121012  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
Code Information Serial Numbers: ACP.357, ACP.388, ACP.396, ACP.397, ACP.399, ACP.400, ACP.402, ACP.404, ACP.405, ACP.407, ACP.408, ACP.409, ACP.410, ACP.412, ACP.413, ACP.416, ACP.417, ACP.418, ACP.419, ACP.420, ACP.421, ACP.422, ACP.423 
Recalling Firm/
Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
Manufacturer Reason
for Recall
The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
FDA Determined
Cause 2
Software design (manufacturing process)
Action The firm sent an Urgent Medical Device Correction letter to all affected customers on March 30, 2020. The letter instructed the customers to complete and return the Customer Letter Receipt Confirmation and Implementation Check form. The firm explained that their regular service provider will contact them to schedule the firmware version upgrade.
Quantity in Commerce 23 units
Distribution Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri
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 = JJE and Original Applicant = INPECO S.P.A.