FDA Enforcement
Class II
Terminated
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.
Recall: Z-3244-2018
·
Reported October 3, 2018
Enforcement
- Recall Number
- Z-3244-2018
- Event ID
- 80585
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tosoh Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- October 3, 2018
- Initiation Date
- July 13, 2018
- Classification Date
- September 25, 2018
- Termination Date
- July 8, 2020
- Address
- 3600 Gantz Rd, Grove City, OH, 43123-1895, United States
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
Analyzers were distributed with software which lacks a 510K
Code Info
Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201
Distribution
US Nationwide Distribution in states of - CA, OK, VA 7 WI
Quantity
8 units