Polymer Technology Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0741-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 15, 2016

Date Posted: January 1, 2020

Recall Number: Z-0741-2020

Event ID: 84264

Reason for Recall:

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

Status: Terminated

Product Quantity: 6467

Code Information:

Lot Number I502, UDI 00381932412018

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated