FDA recall Z-2444-2021

Product

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

US Nationwide distribution

Key facts

Status

Terminated

Initiation date

2021-06-24

Report date

2021-09-22

Termination date

2023-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2444-2021