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U.S. Department of Health and Human Services

Class 2 Device Recall cobas pro integrated solutions

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 Class 2 Device Recall cobas pro integrated solutionssee related information
Date Initiated by FirmDecember 08, 2020
Create DateDecember 30, 2020
Recall Status1 Open3, Classified
Recall NumberZ-0755-2021
Recall Event ID 86981
510(K)NumberK191899 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductRoche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
Code Information Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10 
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactRoche Customer Support Center
317-521-4343
Manufacturer Reason
for Recall		Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
FDA Determined
Cause 2		Software design
ActionRoche recall issued Urgent Medical Device Correction (UMDC TP-01165 and UMDC TP-01169) notifications on 12/8/2020 via UPS Ground (receipt required). Both UMDCs will also be posted to the diagnostics.roche.com website. Letter states reason for recall, health risk and action to take: Consignee Instructions: Inform any operators who use the cobas 8000 modular analyzer series or the cobas pro integrated solutions of the potential hazards associated with this issue and provide a copy of the UMDC notification, as appropriate. Follow the actions outlined in the Customer Actions to Determine if the Issue Has Occurred section of the UMDC. Confirm that you have backed up your most recent settings. Repeat this maintenance function whenever a system setting is changed. Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Complete the enclosed faxback form and return it following the instructions on the form. File this UMDC for future reference. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Quantity in Commerce7 units
DistributionUS Nationwide distribution.
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 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) Database510(K)s with Product Code = JJE
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