Home / Recalls / Polymer Technology Systems / Z-0685-2020

Z-0685-2020 Class II Terminated

Recalled by Polymer Technology Systems — Whitestown, IN

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
20,825

Product Description

ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

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: 1606319 1606405 1606460 1610622 1610910 1611163

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