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Class 2 Device Recall Cobas infinity central lab; Cobas infinity core |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
December 17, 2020 |
Create Date |
January 22, 2021 |
Recall Status1 |
Terminated 3 on May 19, 2023 |
Recall Number |
Z-0883-2021 |
Recall Event ID |
87040 |
Product Classification |
Calculator/data processing module, for clinical use - Product Code JQP
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Product |
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data
Catalog Number: 07154003001 |
Code Information |
All versions from cobas infinity version 3.00.00 onwards |
Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, Inc. 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact |
Roche Customer Support Center 800-428-2336
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Manufacturer Reason for Recall |
A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality.
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FDA Determined Cause 2 |
Software design |
Action |
Roche issued Urgent Medical Device Correction, (UMDC TP-01176) via UPS Ground (receipt required) on 12/17/20. The UMDC TP-01176 will also post to the diagnostics.roche.com website.
Letter states reason for recall, health risk and action to take:
Complete the enclosed faxback form, TP-01177, and return it following the instructions on the form even if
you are not using the Cross SI option.
" If you are using the Cross SI option, refer to the Workarounds section of this Urgent Medical Device
Correction (UMDC) until the Service Patch for your cobas¿ infinity central lab is available for this issue.
" File this UMDC for future reference
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 Commerce |
76 licenses |
Distribution |
US Nationwide |
Total Product Life Cycle |
TPLC Device Report
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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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