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Recall

Class II — Polymer Technology Systems, Inc.

Recalling firmPOLYMER TECHNOLOGY SYSTEMS, INC.
Registered facilityPolymer Technology Systems (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonPotential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
ProductPTS Panels® CHOL+GLU Test Strips (REF 1765)
QuantityN/A
DistributionOH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
Initiated2018-03-14
Classified2018-04-28
Terminated2018-09-13
Recall numberZ-1543-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Polymer Technology Systems, Inc. (Z-1543-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79778/

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