Class II — Polymer Technology Systems
| Recalling firm | POLYMER TECHNOLOGY SYSTEMS, INC. |
|---|---|
| Registered facility | Polymer Technology Systems (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 |
| Quantity | 20,825 |
| Distribution | 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, L… |
| Initiated | 2016-12-02 |
| Classified | 2019-12-13 |
| Terminated | 2020-07-16 |
| Recall number | Z-0685-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Polymer Technology Systems (Z-0685-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84231/
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