A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
This recall has been terminated (originally issued December 17, 2020).
- Recall Initiated
- December 17, 2020
- Terminated
- May 19, 2023
- Recall Number
- Z-0883-2021
- Quantity
- 76 licenses
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide
Lot / Code Info
All versions from cobas infinity version 3.00.00 onwards
Root Cause
Software design
Action Taken
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