Recall Z-2563-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Operations, Inc.
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
| Date | Sep 1, 2014 (initiated Jul 31, 2014) |
| Status | Terminated |
| 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). |
| Root cause | Software design |
| Action | Roche sent an Urgent Medical Device Correction letter dated July 31, 2014 via UPS Ground (receipt required) to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to follow the steps provided in the letter to prevent assigning patient results to an incorrect generic patient ID. Please contact the Roche Support Network Customer Support Center at 1-800-440-3638, prompt 5, 24 hours a day, seven days a week if you have questions about the information contained in this UMDC. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.