FDA recall Z-1232-2020

Product

Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520

Reason for recall

There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2019-12-18

Report date

2020-02-26

Termination date

2020-06-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1232-2020