Home / Recalls / Polymer Technology Systems, Inc. / Z-0834-2020

Z-0834-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
January 29, 2020
Initiation Date
December 2, 2019
Termination Date
July 6, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44,448

Product Description

Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036

Reason for Recall

One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

Distribution Pattern

The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad, UAE.

Code Information

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040040539

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-0835-2020 Class II — Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with ca (December 2, 2019)
  • Z-0833-2020 Class II — PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, wit (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-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)