Reported Jun 5, 2013 · Terminated

PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals…

Polymer Technology Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Polymer Technology Systems, Inc. · 7736 Zionsville Rd · Indianapolis, IN · 46268-2175

Is this the product you have?

  • PTS PANELS, Glucose Test Strips for use with CardioChek
  • Brand Analyzers Product Usageused by healthcare professionals and individuals with diabetes to measure glucose in whole blood
Lot codes and dates
  • U1117
Amount recalled
7048 total, 3499 in USA

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 16, 2014 · Data as of Sep 19, 4:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.