Recall Z-1373-2019— Polymer Technology Systems, Inc.

Name: FDA recall Z-1373-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-16

Class II · Terminated

Class II FDA medical device recall by Polymer Technology Systems, Inc., initiated 2019-01-16, terminated 2020-06-24. It names 2 FDA 510(k) clearances: K182781, K071507. Product: CHOL+HDL+GLU test strips, REF 2412. Reason: 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.

Recalling firm: Polymer Technology Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-01-16
Terminated: 2020-06-24
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K182781 — PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics·cleared 2018-12-21
K071507 — PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPSPolymer Technology Systems, Inc.·cleared 2007-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CHOL+HDL+GLU test strips, REF 2412

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.