FDA-Device2013-06-05Class II
PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
Polymer Technology Systems, Inc.
Hazard
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
Sold states
Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.
Affected count
7048 total, 3499 in USA
Manufactured in
7736 Zionsville Rd, N/A, Indianapolis, IN, United States
Products
PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2013Don't want to check this manually?
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