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Polymer Technology Systems, Inc. recalls PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare profession
Recalled June 5, 2013 · FDA recall Z-1403-2013 · Polymer Technology Systems
Hazard
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk. · FDA Class II
Units
7048 total, 3499 in USA
Sold at
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.
Description
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
Product
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
Manufacturer(s)
Polymer Technology Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →