Cobas 8100 bi-directional recall: Software Issue
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Why was Cobas 8100 bi-directional recalled?
"Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over."
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?
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: 743995400
- Product
- Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 45 Units
- Distribution
- Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
- Recall date
- April 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)