—#129001

Product

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

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Part Numbers: 04420306001 Serial #'s: 2706, 2724, 2743, 2744, 2745, 2749, 2750, 2751, 2752, 2754, 2755, 2764, 2770, 2771, 2772, 2773, 2774, 2775, 2776, 2780, 2781, 2782, 2783, 2784, 2785, 2789, 2790, 2791, 2792, 2793, 2794, 2795, 2796, 2797, 2798, 2799, 2808, 2814, 2815, 2816, 2818, 2819, 2823, 2824, 2825, 2826, 2828, 2829, 2830, 2831, 2847, 2848, 2849, 2857, 2858, 2859, 2860, 2861, 2862, 2863, 2864, 2865, 2904, 2905, 2906, 2908, 2909, 2914, 2915, 2916, 2917, 2920, 2921, 2928, 2931, 2932, 2933, 2934, 2935, 2936, 2937, 2938, 2939, 2940, 2941, 2943, 2983, 2984, 2985, 2986, 2987, 2990, 2991, 2992, 2993, 2994, 2995, 2996, 2997, 2998, 3006, 3007, 3008, 3009, 3016, 3020, 3021, 3023, 3024, 3025, 3026, 3027, 3048, 3049, 3050, 3051, 3053, 3057, 3058, 3059, 3060, 3061, 3065, 3066, 3067, 3068, 3069, 3070, 3071, 3072, 3073, 3074, 3075, 3076, 3077, 3079, 3082, 3083, 3084, 3085, 3086, 3087, 3089, 3090, 3104, 3105, 3106, and 3107.

Why it was 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).

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-07-31
Posted by FDA: 2014-09-01
Terminated: 2015-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.