Home / Recalls / Polymer Technology Systems, Inc. / Z-1372-2019

Z-1372-2019 Class II Terminated

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

FDA device recall Z-1372-2019 was initiated by Polymer Technology Systems, Inc. on January 16, 2019 and is designated Class II. 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 di P832 Chemistry (Diagnostic) CHH 2 Lipid Pane… The recall status is terminated (terminated June 24, 2020). Affected quantity: 67643 total.

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

Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

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 di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

Distribution Pattern

Domestic distribution nationwide.

Code Information

Q802 Q811 Q813 Q816 Q820 Q823 Q831 Q903

Other recalls by Polymer Technology Systems, Inc.

  • Z-1438-2020 Class II — PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Produ (January 21, 2020)
  • Z-0833-2020 Class II — PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, wit (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-0832-2020 Class II — PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with (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-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)
  • Z-1543-2018 Class II — PTS Panels¿ CHOL+GLU Test Strips (REF 1765) (March 14, 2018)

FDA data resources