Home / Recalls / Polymer Technology Systems, Inc. / Z-1438-2020

Z-1438-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
March 11, 2020
Initiation Date
January 21, 2020
Termination Date
December 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6790

Product Description

PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.

Reason for Recall

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

Distribution Pattern

Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.

Code Information

1811715 1831313 1831324 1831325

Other recalls by Polymer Technology Systems, Inc.

  • Z-0835-2020 Class II — Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with ca (December 2, 2019)
  • Z-0832-2020 Class II — PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with (December 2, 2019)
  • Z-0833-2020 Class II — PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, wit (December 2, 2019)
  • Z-0834-2020 Class II — Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 (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-1373-2019 Class II — CHOL+HDL+GLU test strips, REF 2412 (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-1372-2019 Class II — Lipid Panel test strips (as a component of smart bundles), REF 2729, also privat (January 16, 2019)
  • Z-1543-2018 Class II — PTS Panels¿ CHOL+GLU Test Strips (REF 1765) (March 14, 2018)