—#185110

Product

A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All versions from cobas infinity version 3.00.00 onwards

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2020-12-17
Terminated: 2023-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185110. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.