Z-2444-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- June 24, 2021
- Termination Date
- July 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2058 licenses worldwide, 79 licenses in US
Product Description
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution
Code Information
UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08