Roche Diagnostics Operations, Inc. cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.

Recommended Action

Per FDA guidance

An Urgent Medical Device Correction notification letter dated 6/24/21 was sent to customers. Actions Required " Follow the Workaround section of this Urgent Medical Device Correction (UMDC), if applicable. " Consult with the physician or pathologist at your facility to determine any clinical implications specific to your patients. " Until the service patch is available, use the workaround described in this UMDC. " Complete all sections of the enclosed faxback form (TP-01337) and fax it to 1-847-457-1389 or email it to roche6071@stericycle.com. " File this UMDC for future reference. Identifying the Issue This issue occurs under specific circumstances and ALL of the conditions listed in the Issue section on page one of this UMDC must be fulfilled in order for the issue to occur. The issue can be identified when: " the current result appears as a repetition in the validation screen, " the Raw result column will appear blank indicating that the current result was not received from the instrument, and " the test alarm REP is triggered that indicates that the test results were repeated. Also, the issue can be detected in the validation screen based on the information that might be shown. The list below may help identify the issue (depending on your system configuration): " The LIS test result differs from the analyzer result. " There is a test alarm indicating the result is a repetition. " There is no analyzer associated with the result. " The main result time differs from some or all of the embedded result times. " The Preliminary result column displays the previous result, which corresponds to the original result sent by the instrument. " The repetition icon indicates the number of repetitions (i.e., 1 or more). Workaround Roche recommends contacting the Roche Support Network Customer Support Center at 1-800-526-2272 to request support for the workaround listed below: The following workaround can be used until the service patches are available to resolve this i