Home / Recalls / Polymer Technology Systems, Inc. / Z-1373-2019

Z-1373-2019 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
May 29, 2019
Initiation Date
January 16, 2019
Termination Date
June 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
67643 total

Product Description

CHOL+HDL+GLU test strips, REF 2412

Reason for Recall

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

Distribution Pattern

Domestic distribution nationwide.

Code Information

I808 I809 I811 I812 I814

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  • Z-2158-2019 Class III — Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref N (June 7, 2019)
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  • 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-1543-2018 Class II — PTS Panels¿ CHOL+GLU Test Strips (REF 1765) (March 14, 2018)