Z-2444-2021 Class II Terminated
FDA device recall Z-2444-2021 was initiated by Roche Diagnostics Operations, Inc. on June 24, 2021 and is designated Class II. 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… The recall status is terminated (terminated July 21, 2023). Affected quantity: 2058 licenses worldwide, 79 licenses in US.
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