FDA recall Z-3244-2018

Product

G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

Reason for recall

Analyzers were distributed with software which lacks a 510K

Distribution

US Nationwide Distribution in states of - CA, OK, VA 7 WI

Key facts

Status

Terminated

Initiation date

2018-07-13

Report date

2018-10-03

Termination date

2020-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grove City, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3244-2018