Roche Recalls cobas e 801 Immunoassay Analyzers Due to Signal Drops
Roche Diagnostics is recalling 149 cobas e 801 immunoassay analyzers because signal drops after bottle changeovers may lead to incorrect medical decisions.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of incorrect medical decisions regarding patient treatment, which aligns with the rubric criteria for Severe severity involving significant injury risk or Class II classifications with potential for serious harm.
Plain-English summary
Roche Diagnostics Corporation is recalling 149 units of the cobas e 801 immunoassay analyzer. The recall was initiated after the firm confirmed complaints regarding signal drops on the cobas e 801 module following a ProCell II M bottle changeover.
These signal drops may lead to incorrect medical decisions regarding diagnostics and patient treatment. The recall is classified as Class II by the U.S. Food and Drug Administration. The affected units were distributed to accounts in Alabama, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin.
Healthcare facilities and accounts that received these units should stop using the affected cobas e 801 analyzers and contact Roche Diagnostics Corporation for further instructions on the recall.
The recalled product
- Product
- cobas e 801 immunoassay analyzer
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 149
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)
- All units may experience this issue.
Distribution
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