medical Class II Updated 2020-01-01

Polymer Technology Systems, Inc. recalls PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412,

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, WI
Lot/Code Info: Lot Number I502, UDI 00381932412018
View official government recall

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