Roche cobas 6000 Modular Series System Warning Added to Prevent Operator Injury
Roche Diagnostics is adding a warning to cobas 6000 and 8000 Modular Series Operator Manuals to prevent 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 source identifies a risk of operator injury during maintenance without reporting specific injuries or illnesses, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Corporation is recalling 3,433 units of the cobas 6000 Modular Series system and related configurations. The affected products include the cobas c 501 module and various cobas 6000 UL configurations. These devices were distributed in all 50 states, the District of Columbia, and Puerto Rico.
The recall is being conducted to add a warning to the cobas 6000 MODULAR Series System - c501 and the cobas 8000 MODULAR Analyzer Series - c502 Operator Manuals. This update is intended to prevent operator injury during maintenance activities. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and operators should check their serial numbers against the list provided by the FDA and contact Roche Diagnostics for instructions on updating their manuals. No specific illnesses or injuries have been reported in the source text, but the hazard is identified as a risk of operator injury during maintenance.
The recalled product
- Product
- cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
- Affected units
- 3,433
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Roche Diagnostics Corporation
See all →- ModerateRoche Tina-quant lgA Gen.2 Assay Recalled Due to Reagent Contamination
FDA (Devices) · 2019-07-24
- LowRoche cobas p 701 Post-Analytical Units Recalled for Loose Flap
FDA (Devices) · 2019-07-10
- LowRoche cobas p 501 Post-Analytical Units Recalled for Loose Flap
FDA (Devices) · 2019-07-10
- HighRoche Cobas infinity Software Recall for Missing Quality Control Alarms
FDA (Devices) · 2019-05-29
- SevereRoche Recalls cobas e 801 Immunoassay Analyzers Due to Signal Drops
FDA (Devices) · 2019-05-08
Same hazard · operator injury
See all →- HighCT Scanner Software Upgrade May Cause Unexpected Table Movement
FDA (Devices) · 2024-04-17
- HighRoche cobas 8000 Modular Analyzer Recall for Operator Injury Prevention
FDA (Devices) · 2018-03-14
- HighRoche Cobas Connection Module Recalled for Vibration and Contamination Risk
FDA (Devices) · 2017-06-14
- SevereSiemens Linear Accelerators Recalled for Unauthorized Component Safety Risks
FDA (Devices) · 2015-01-21