Home / Recalls / Polymer Technology Systems, Inc. / Z-1543-2018

Z-1543-2018 Class II Terminated

Recalled by Polymer Technology Systems, Inc. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
May 9, 2018
Initiation Date
March 14, 2018
Termination Date
September 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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

Reason for Recall

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

Distribution Pattern

OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England

Code Information

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

Other recalls by Polymer Technology Systems, Inc.

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  • Z-0832-2020 Class II — PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with (December 2, 2019)
  • Z-0835-2020 Class II — Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with ca (December 2, 2019)
  • Z-0834-2020 Class II — Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 (December 2, 2019)
  • Z-0833-2020 Class II — PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, wit (December 2, 2019)
  • Z-2158-2019 Class III — Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref N (June 7, 2019)
  • Z-2157-2019 Class III — PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 171 (June 7, 2019)
  • Z-1372-2019 Class II — Lipid Panel test strips (as a component of smart bundles), REF 2729, also privat (January 16, 2019)
  • Z-1371-2019 Class II — Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as RE (January 16, 2019)
  • Z-1373-2019 Class II — CHOL+HDL+GLU test strips, REF 2412 (January 16, 2019)