Medical device recalls Moderate risk

Polymer Technology Systems, Inc. recalls CHOL+HDL+GLU test strips, REF 2412

Recall date
January 16, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1373-2019
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

CHOL+HDL+GLU test strips, REF 2412

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