Polymer Technology Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1373-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

CHOL+HDL+GLU test strips, REF 2412

Product Classification:

Class II

Date Initiated: January 16, 2019

Date Posted: May 29, 2019

Recall Number: Z-1373-2019

Event ID: 82331

Reason for Recall:

Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed

Status: Terminated

Product Quantity: 67643 total

Code Information:

I808 I809 I811 I812 I814

Distribution Pattern:

Domestic distribution nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated