FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
- Recall number
- Z-2563-2014
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
- Status
- Terminated
- Initiated
- 2014-07-31
- Posted
- 2014-09-01
- Terminated
- 2015-06-16
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28