Roche cobas 8000 Modular Analyzer Recall for Potential Configuration Errors
Roche is recalling cobas 8000 modular analyzers because configuration settings may change, causing incorrect results that could go undetected.
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 incorrect results could impact patient care, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 1,050 units of the cobas 8000 modular analyzer series, including the ISE module, cobas c 502, 701, and 702 modules, and cobas e 602 and 801 modules. The recall covers units distributed nationwide in the United States.
The recall is due to a potential for changed configuration settings on the cobas 8000 modular analyzer series and cobas pro integrated solutions. This issue may cause incorrect results in several affected parameters. In cases of poor sample quality, discrepant results may remain undetected because associated data flags are absent.
Healthcare facilities and laboratories using these devices should contact Roche Diagnostics Operations, Inc. for instructions on how to address the configuration settings and ensure accurate testing results.
The recalled product
- Product
- Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 1,050
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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