Home / Recalls / Polymer Technology Systems, Inc. / Z-1403-2013

Z-1403-2013 Class II Terminated

Recalled by Polymer Technology Systems, Inc. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
June 5, 2013
Initiation Date
April 4, 2013
Termination Date
April 16, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7048 total, 3499 in USA

Product Description

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

Reason for Recall

Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.

Distribution Pattern

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.

Code Information

U1117

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