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Roche Diagnostics Operations, Inc. recalls Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process labor
Recalled September 10, 2014 · FDA recall Z-2563-2014 · Roche Diagnostics Operations
Hazard
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). · FDA Class II
Units
148 Units
Sold at
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.
Description
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).
Product
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →