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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

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
Recall Number Z-1403-2013
Classification Class II
Code Info U1117
Product Distributed Qty 7048 total, 3499 in USA
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.

Event Detail

Event Id 65067
Product Type Devices
Status Ongoing
Recalling Firm Polymer Technology Systems, Inc.
City Indianapolis
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-04
Initial Firm Notification of Consignee or Public Letter
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.