Roche cobas IT 1000 Product Usage: Intended Use: An electronic device… — Class II medical device recall Z-2563-2014
Terminated recall by Roche Diagnostics Operations, Inc., reported 2014-09-10, distributed nationwide. Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives an ADT ADMIT,
| Recall number | Z-2563-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2014-07-31 |
| Classified | 2014-09-01 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2015-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 148 units |
| Serial numbers | 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 and 123 more |
| Model numbers | 04420306001 |
Product
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2563-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.