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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 licensesee related information
Date Initiated by FirmJanuary 07, 2020
Create DateFebruary 12, 2020
Recall Status1 Terminated 3 on October 15, 2020
Recall NumberZ-1158-2020
Recall Event ID 84697
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Productcobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Code Information All cobas infinity laboratory solution software versions are affected.
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactRoche customer support center
800-428-2336
Manufacturer Reason
for Recall		Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 1/7/2020, the firm distributed Urgent Medical Device Correction letters to affected consignees. Customers were asked to do the following: " Be aware of the incorrect display of the alarm flags on the cobas infinity Validation screen if an alarm has a < symbol in front of it and if doing manual validations. " It is not recommended to use the alarm mapping function on the cobas infinity until your system is patched. If your laboratory does use it, please call the Roche Support Network Customer Support Center at 1-800-526-2272 for further information. " Complete the customer response form and return it to the recalling firm. Please 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 about the information contained in this UMDC.
Quantity in Commerce26 accounts
DistributionDistributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.
Total Product Life CycleTPLC 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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