Company: Roche Diagnostics Operations, Inc.
Date of Enforcement Report: 9/10/2014
Class lI:
PRODUCT
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
Recall Number Z-2563-2014
REASON
It has been internally found that if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that contains a genuine Patient ID (e.g. 999999), which is the same as what has been configured in cobas IT 1000 as the Generic Patient ID (999999 by default) it can assign previously stored generic patient test results to the newly created patient ID. This issue has not been reported by any customers; however the outcome of the issue is that test results would be assigned to the wrong Patient ID.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN on 7/31/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
148 Units
DISTRIBUTION
Nationwide
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