Z-2563-2014Class II

Roche cobas IT 1000

Name: Z-2563-2014 Roche cobas IT 1000
Creator: Roche Diagnostics Operations, Inc.
Published: 2014-07-31
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2014-07-31 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data on 2014-07-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2563-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-31
Posted: 2014-09-01
Terminated: 2015-06-16
Recalling firm: Roche Diagnostics GmbH
Product: Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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).
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2563-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2563-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-01

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)