Medical device recalls Moderate risk

Polymer Technology Systems, Inc. recalls PTS Panels¿ CHOL+GLU Test Strips (REF 1765)

Recall date
March 14, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1543-2018
FDA classification
Class II
Brand / firm
Polymer Technology Systems, Inc.
Sold / distributed
OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England

Why it was recalled

Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)

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

What was recalled

PTS Panels¿ CHOL+GLU Test Strips (REF 1765)

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