Home / Recalls / Polymer Technology Systems / Z-0683-2020

Z-0683-2020 Class II Terminated

Recalled by Polymer Technology Systems — Whitestown, IN

FDA device recall Z-0683-2020 was initiated by Polymer Technology Systems on December 2, 2016 and is designated Class II. Reason for recall: A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. The recall status is terminated (terminated July 16, 2020). Affected quantity: 500.

Recall Details

Product Type: Devices
Report Date: December 25, 2019
Initiation Date: December 2, 2016
Termination Date: July 16, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 500

Product Description

A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062

Reason for Recall

A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.

Distribution Pattern

The products were distributed to the following US states: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI TN, UT, VA, WA, and Puerto Rico. The products were distributed to the following foreign countries: Australia, Bahamas, Belgium, Bahrain, Bangladesh, Canada, China, Columbia, Czech Republic, England, Egypt, Greece, Spain, India, Indonesia, Haiti, Hong Kong, Italy, Japan, Jordan, Kenya, Lebanon, Mexico, Myanmar, Malaysia, Philippines, Pakistan, South Africa, Nigeria, Poland, Saudi Arabia, Sweden, Turkey, Singapore, Trinidad & Tobago, Slovenia, Vietnam, United Arab Emirates, Uruguay.

Code Information

Lot Numbers: 1610622 1618153

Other recalls by Polymer Technology Systems

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-1372-2019 Class II — Lipid Panel test strips (as a component of smart bundles), REF 2729, also privat (January 16, 2019)
Z-1373-2019 Class II — CHOL+HDL+GLU test strips, REF 2412 (January 16, 2019)