Recall Z-1372-2019— Polymer Technology Systems, Inc.

Name: FDA recall Z-1372-2019
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 one FDA 510(k) clearance: K023558. Product: Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412. 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 di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412.

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

1 on FDA's record

K023558 — PTS PANELS LIPID PANEL TEST STRIPSPolymer Technology Systems, Inc.·cleared 2002-11-15

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

Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

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 di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

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