Polymer Technology Systems: Medical Device Recall in 2019 - (Recall #: Z-0683-2020)

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:

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

Product Classification:

Class II

Date Initiated: December 2, 2016

Date Posted: December 25, 2019

Recall Number: Z-0683-2020

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: 500

Code Information:

Lot Numbers: 1610622 1618153

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