Roche cobas pro integrated solutions recalled for potential incorrect results
Roche Diagnostics is recalling 7 cobas pro integrated solutions units because configuration settings may cause incorrect clinical results that remain undetected.
What this means for you
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 high-risk medical device where incorrect clinical results may occur without detection, posing a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 7 units of the Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer. The affected units have serial numbers 1925-10, 1931-04, 1931-05, 1931-07, 1937-10, 1938-01, and 1942-10. These devices were 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 clinical laboratories should contact Roche Diagnostics Operations, Inc. for instructions on how to address the configuration settings and ensure accurate clinical results.
The recalled product
- Product
- Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 7
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 (7)
- Serial Numbers: 1925-10
- 1931-04
- 1931-05
- 1931-07
- 1937-10
- 1938-01
- 1942-10
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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