Z-3244-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 3, 2018
- Initiation Date
- July 13, 2018
- Termination Date
- July 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
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 Pattern
US Nationwide Distribution in states of - CA, OK, VA 7 WI
Code Information
Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201