Home / Recalls / Polymer Technology Systems, Inc. / Z-2157-2019

Z-2157-2019 Class III Terminated

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

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
June 7, 2019
Termination Date
July 8, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,887 vials US; 2,728 vials OUS

Product Description

PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

Reason for Recall

The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901

Distribution Pattern

Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan

Code Information

Lot Number: P901 Exp. Date: 8/17/2020 (01) 00381931710016 (17) 200817 (10) P901

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-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-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)
  • Z-1543-2018 Class II — PTS Panels¿ CHOL+GLU Test Strips (REF 1765) (March 14, 2018)