Polymer Technology Systems, Inc. recalls Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414

Recall date

January 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1371-2019

FDA classification

Class II

Brand / firm

Polymer Technology Systems, Inc.

Sold / distributed

Domestic distribution nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414