cobas infinity central lab running software version recall
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Why was cobas infinity central lab running software version recalled?
Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
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?
UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08
- Product
- cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 2058 licenses worldwide, 79 licenses in US
- Distribution
- US Nationwide distribution
- Recall date
- September 22, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)