Polymer Technology Systems, Inc. recalls PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

Recall date

March 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0741-2020

FDA classification

Class II

Brand / firm

Polymer Technology Systems, Inc.

Sold / distributed

The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.

Why it was recalled

This lot of test strips is showing an under-recovery when tested against a reference method.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers