The Recall Desk
ModerateFDA (Devices)·Z-1543-2018·Announced 2018-05-09

PTS CHOL+GLU Test Strips Recalled for Potential Loss of Glucose Activity

Polymer Technology Systems is recalling PTS Panels CHOL+GLU Test Strips due to a potential loss of glucose analyte activity before the stated shelf life.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential loss of activity without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Polymer Technology Systems, Inc. is recalling PTS Panels CHOL+GLU Test Strips (REF 1765). The recall is due to a potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life of August 2018.

The affected product is identified by Lot # A705 and UDI (01)00381931765016(17)180813(10)A705. The product was distributed in Ohio, Puerto Rico, Virginia, California, Illinois, Florida, Washington, Tennessee, Kentucky, Minnesota, New York, Belgium, Hong Kong, Sweden, Australia, Russia, Brazil, and England.

Consumers and healthcare providers should stop using the affected test strips and contact the manufacturer for further instructions or a replacement.

The recalled product

Product
PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
Manufacturer
Polymer Technology Systems, Inc.
Category
Medical Device — Diagnostic Test Strips
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # A705 UDI (01)00381931765016(17)180813(10)A705

Distribution

Distributed in 10 states:

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