Home / Recalls / Polymer Technology Systems, Inc. / Z-1903-2012

Z-1903-2012 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
July 4, 2012
Initiation Date
May 15, 2012
Termination Date
July 20, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1650 vials

Product Description

PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample

Reason for Recall

During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.

Distribution Pattern

Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.

Code Information

Cat No. 1720; and Lot number F103

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