Polymer Technology Systems, Inc. recalls Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570…

Recall date

January 16, 2019

Source

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

Recall number

Z-1372-2019

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 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

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