Recall Z-2563-2014— Roche Diagnostics Operations, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2014-07-31, terminated 2015-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.. Reason: Potential that test results would be assigned to the wrong Patient ID 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 as the Generic Patient ID (999999 by default)..
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-31
- Terminated
- 2015-06-16
- Firm location
- Indianapolis, IN, United States
Product description
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
Reason for recall
Potential that test results would be assigned to the wrong Patient ID 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 as the Generic Patient ID (999999 by default).
Data sourced from openFDA. This site is unofficial and independent of the FDA.