Roche Diagnostics Operations, Inc. A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
All versions from cobas infinity version 3.00.00 onwards
Products Sold
All versions from cobas infinity version 3.00.00 onwards
Roche Diagnostics Operations, Inc. is recalling A calculator/data processing module for clinical use is an electronic device intended to store, retr due to A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifini. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026