Roche cobas 8000 Modular Analyzer Recall for Operator Injury Prevention
Roche Diagnostics is recalling 245 cobas 8000 c 502 modules to add a warning to the manual, preventing operator injury during maintenance.
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 risk-of-harm product (operator injury) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Roche Diagnostics Corporation is recalling 245 units of the cobas 8000 Modular Analyzer Series, specifically the cobas 8000 c 502 module (Part Number 05964067001). The recall is being conducted to add a warning to the cobas 6000 analyzer and cobas 8000 modular analyzer series Operators Manual. This update is intended to prevent operator injury during maintenance activities.
The affected units were distributed in all 50 states, the District of Columbia, and Puerto Rico. The recall includes specific serial numbers listed in the agency's documentation. No illnesses or injuries have been reported in the source text.
Healthcare facilities and operators should check their equipment serial numbers against the provided list. If a unit is affected, the manufacturer is adding the necessary warning to the manual to ensure safety during maintenance.
The recalled product
- Product
- cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
- Affected units
- 245
Distribution
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Corporation 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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