Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
Reported: September 10, 2014 Initiated: July 31, 2014 #Z-2563-2014
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).
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 148 Units
- Distribution
- US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, NE, NH, NJ, NY, OH, OR, PA, PR, SC, TN, TX, VA, VT, WA, WI, and WV.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 148 Units.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2014. Severity: Moderate. Recall number: Z-2563-2014.
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