Recall Z-1403-2013— Polymer Technology Systems, Inc.

Name: FDA recall Z-1403-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-04

Class II · Terminated

Class II FDA medical device recall by Polymer Technology Systems, Inc., initiated 2013-04-04, terminated 2014-04-16. It names one FDA 510(k) clearance: K013068. 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. Reason: Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk..

Recalling firm: Polymer Technology Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Terminated: 2014-04-16
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K013068 — BIOSCANNER 2000Polymer Technology Systems, Inc.·cleared 2001-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.