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Polymer Technology Systems, Inc. recalls PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Recalled January 1, 2020 · FDA recall Z-0741-2020 · Polymer Technology Systems
Hazard
This lot of test strips is showing an under-recovery when tested against a reference method. · FDA Class II
Units
6467
Sold at
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.
Description
This lot of test strips is showing an under-recovery when tested against a reference method.
Product
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Manufacturer(s)
Polymer Technology Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →