Roche cobas e 601 Module Recalled for Inaccurate Results
Roche Diagnostics is recalling cobas e 601 modules due to a quality issue with high pressure solenoid valves that may cause inaccurate 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 is classified as FDA Class II and involves a risk of harm (inaccurate medical test results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling one unit of the cobas e 601 module (cobas 6000 Modular Series system), Part Number 04745922001. The recall is due to a quality issue with high pressure solenoid valves that may cause inaccurate results.
The affected unit has Serial Number 31A1-01. The product was distributed in the states of New York, Montana, Hawaii, Indiana, Maryland, Texas, Ohio, Kansas, Kentucky, California, Florida, Oregon, Louisiana, Missouri, and Alaska.
Healthcare facilities and laboratories should contact Roche Diagnostics for further instructions regarding the return or replacement of the affected module.
The recalled product
- Product
- cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 1
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 (1)
- Serial # : 31A1-01
Distribution
Part of a larger recall action
This product is one of 3 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.
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