FDA recall Z-1368-2019

Product

Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use

Reason for recall

Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.

Distribution

US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.

Key facts

Status

Terminated

Initiation date

2019-02-04

Report date

2019-05-29

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2019