Roche COBAS INTEGRA c111 Analyzer Recall for Software Error
Roche is recalling 139 COBAS INTEGRA c111 analyzers due to a software error that may cause erroneous test results.
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 where erroneous diagnostic results could lead to incorrect medical decisions, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 139 units of the Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use. The affected units are catalog numbers 04777433001 (with ISE) and 04528778001 (without ISE) with software versions up to and including 4.20. These devices were distributed nationwide in the United States.
The recall is due to a software error that may generate alarm 7002: 108000572. Under very rare conditions, a measurement timing error may cause the instrument to process two tests in the same cuvette if the run restarts. If a used cuvette is used again, the resulting test results will be erroneous and may not be flagged by the system.
Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the specific parameter being tested. Healthcare facilities should contact Roche Diagnostics Operations, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are…
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 139
Distribution
Distributed nationwide across the United States.
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