Roche AssayTip/AssayCup Tray Recall for Abnormal Internal Structure
Roche Diagnostics is recalling AssayTip/AssayCup Trays used on the cobas e 801 module due to abnormal internal structure that may lead to incorrect patient 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 involves a risk-of-harm product (incorrect patient results) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 935 units of AssayTip/AssayCup Trays, Catalog Number 5694302001. These trays are used on the cobas e 801 module, which is part of the cobas c 8000 MODULAR Analyzer Series used for in vitro determination of analytes in human body fluids.
The recall is being conducted because the AssayTips may have an abnormal internal structure. This defect may lead to incorrect patient results. The affected lot numbers are 18636170, 18665170, 18667170, 18668170, 18215274, 18245274, 18250274, 18251274, 18252274, 18253274, 18265274, 18271274, and 19209274.
The product was distributed nationwide. Healthcare facilities and laboratories using the cobas e 801 module should stop using the affected trays and contact Roche Diagnostics for further instructions.
The recalled product
- Product
- AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 935
Distribution
Distributed nationwide across the United States.
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