FDA recall Z-1158-2020

Product

cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

Reason for recall

Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.

Distribution

Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.

Key facts

Status

Terminated

Initiation date

2020-01-07

Report date

2020-02-19

Termination date

2020-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1158-2020