Cobas infinity central lab / cobas infinity core recall
Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
Why was Cobas infinity central lab / cobas infinity core recalled?
Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
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 infinity software version 2.4.1 through 2.5.4
- Product
- Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 20
- Distribution
- US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN
- Recall date
- February 5, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)