Roche Diagnostics Operations, Inc. Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Roche Diagnostics Operations, Inc. is recalling Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retriev due to 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 co. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026