Cobas connection module recall: Contamination
Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to…
Why was Cobas connection module recalled?
a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the 5 position racks during the transport. This issue can pose a potential risk to involved operators and can also lead to potential cross contamination of samples in the affected racks.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number 204C5690 204H0157 204H0158
- 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…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 3
- Distribution
- US distribution to WA only.
- Recall date
- June 14, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)