Skip to content

cobas infinity central lab running software version 3.01.03… recallZ-2444-2021 · Roche Diagnostics Operations, Inc. · initiated Jun 24, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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 [email protected]. " 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

Recall details

Recall number
Z-2444-2021
Status
Terminated
Initiated by the company
Jun 24, 2021
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
2058 licenses worldwide, 79 licenses in US
Product code
JQP
Distribution
US Nationwide distribution

Product description

cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

Code information (models, lots, serial numbers)

UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page