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U.S. Department of Health and Human Services

Class 2 Device Recall cobas infinity central lab / cobas infinity core license

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  Class 2 Device Recall cobas infinity central lab / cobas infinity core license see related information
Date Initiated by Firm October 08, 2019
Create Date January 30, 2020
Recall Status1 Terminated 3 on October 15, 2020
Recall Number Z-0922-2020
Recall Event ID 84128
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use
Material Number: 07154003001
Code Information Cobas infinity software version 2.4.1 through 2.5.4
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Customer Support Center
800-428-2336
Manufacturer Reason
for Recall		 Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
FDA Determined
Cause 2		 Software design
Action Roche issued Urgent Medical Device Correction TP-00791 mailed via UPS Ground (receipt required) on 10/8/2019. The letter identifies the problem, health risk and action to take: Complete the attached fax form (TP-00792) and fax or email it according to the instructions on the form. " File this Urgent Medical Device Correction (UMDC) for future reference Roche will resolve this issue in a future software update. In the next couple of weeks, a Roche Representative will be contacting you to adjust alarm code mapping as needed per your specific configuration. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-526-2272 if you have questions. The UMDC will also post to the diagnostics.roche.com website
Quantity in Commerce 20
Distribution US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN
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.
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