Glucose Oxidase, Glucose
Polymer Technology Systems's record for this product code
Recent MDR events
2 adverse event reports on file
Recalls
3 recall events for this product code
- TerminatedMar 5, 2010
Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence.
View FDA record ↗ - TerminatedUnknown
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
View FDA record ↗ - CompletedUnknown
Incorrect instructions for use were packaged into the final product.
View FDA record ↗
510(k) clearances
6 clearances for this product code
- K182781Dec 21, 2018
PTS Professional Chemistry Kit
- K162282Dec 22, 2016
CardioChek Plus Test System, CardioChek Home Test System
- K151530Jul 7, 2015
CardioChek Plus Test System
- K142302Oct 2, 2014
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
- K013068Nov 20, 2001
BIOSCANNER 2000
- K972669Jan 22, 1998
MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON