Polymer Technology Systems: Medical Device Recall in 2019 - (Recall #: Z-0685-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 2, 2016

Date Posted: December 25, 2019

Recall Number: Z-0685-2020

Event ID: 84231

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.

Status: Terminated

Product Quantity: 20,825

Code Information:

Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163

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.

Voluntary or Mandated:

Voluntary: Firm initiated