Roche Cobas Connection Module Recalled for Vibration and Contamination Risk
Roche Diagnostics is recalling three Cobas connection modules in Washington due to a gap that may cause rack vibration, posing operator injury and sample cross-contamination risks.
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 and sample cross-contamination) where no specific injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Roche Diagnostics Corporation is recalling three units of the Cobas connection module (CCM) - OUTPUT UNIT. The recall is limited to units distributed in Washington. The affected serial numbers are 204C5690, 204H0157, and 204H0158.
The recall is due to a gap between the conveyor belt and the rack tray table, which is a plastic part. This gap may cause the 5-position racks to vibrate during transport. The vibration poses a potential risk to involved operators and can lead to potential cross-contamination of samples in the affected racks.
The Cobas connection module enables a unidirectional connection of pre-analytical systems to analysis instruments from Roche Diagnostics, Hitachi, or Sysmex via the Aloka transportation system. Users should contact Roche Diagnostics for further instructions on handling the affected units.
The recalled product
- Product
- Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 3
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)
- Serial Number 204C5690 204H0157 204H0158
Distribution
Distributed in 1 state:
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