Roche cobas IT 1000 Recalled for Potential Patient ID Mismatch
Roche Diagnostics is recalling 148 cobas IT 1000 devices because they may assign test results to the wrong patient ID if specific system messages are received.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential patient safety risks without confirmed adverse events.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 148 units of the cobas IT 1000, an electronic device intended to store, retrieve, and process laboratory data. The recall is due to a potential software issue where test results could be assigned to the wrong Patient ID. This error may occur if the device receives an ADT ADMIT, TRANSFER, or MERGE event message containing a genuine Patient ID that matches the configured Generic Patient ID (which defaults to 999999).
The affected units were distributed nationwide in the United States, including the District of Columbia and Puerto Rico. The recall covers specific serial numbers ranging from 2706 to 3107. No illnesses or injuries have been reported in connection with this recall.
Healthcare facilities should contact Roche Diagnostics for instructions on how to address the issue. Users should verify that test results are correctly associated with the intended patient to prevent potential misdiagnosis or treatment errors.
The recalled product
- Product
- Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 148
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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