Device 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.
Z-3244-2018
Product summary
- Event
- Event 80585
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-3244-2018
Official wording
Reason: Analyzers were distributed with software which lacks a 510K
Code information: Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201
Distribution pattern: US Nationwide Distribution in states of - CA, OK, VA 7 WI
Derived failure modes
-
Unknown
Analyzers were distributed with software which lacks a 510K