Roche cobas e 801 Immunoassay Analyzer Recalled for Plunger Defect
Roche Diagnostics is recalling 35 cobas e 801 immunoassay analyzers because a tilted syringe plunger may crack, leading to impaired syringe function.
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. The hazard involves a mechanical defect that could impair the function of a medical device used for in vitro diagnostics, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Corporation is recalling 35 units of the cobas e 801 immunoassay analyzer, part of the cobas 8000 Modular Series. The device is a fully automated, software-controlled analyzer system used for the in vitro determination of analytes in human body fluids. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is due to a defect where the syringe plunger may be mounted in a tilted position. This tilt applies mechanical stress to the plunger, which may cause it to crack in the worst-case scenario. A cracked plunger leads to impaired syringe function.
The affected units were distributed to the states of California, Connecticut, Iowa, Indiana, Kentucky, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Texas, and Virginia. Specific serial numbers are listed in the official recall notice. Users of these devices should contact Roche Diagnostics Corporation for further instructions on the recall.
The recalled product
- Product
- cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent…
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 35
Distribution
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