Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laborator

FDA device recall Z-2563-2014 · posted 2014-09-01 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

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).

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity 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.

Date initiated

2014-07-31

Date posted

2014-09-01

Date terminated

2015-06-16

Location

Indianapolis, IN