FDA recall Z-0752-2021

Product

cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

Reason for recall

During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).

Distribution

Domestic: IL, FL, GA, WV

Key facts

Status

Terminated

Initiation date

2020-11-23

Report date

2021-01-06

Termination date

2023-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0752-2021