cobas infinity core recall
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Why was cobas infinity core recalled?
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
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?
All cobas infinity laboratory solution software versions are affected.
- Product
- cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 26 accounts
- Distribution
- Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)