Class II — Polymer Technology Systems, Inc.
| Recalling firm | POLYMER TECHNOLOGY SYSTEMS, INC. |
|---|---|
| Registered facility | Polymer Technology Systems (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk. |
| Product | PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood |
| Quantity | 7048 total, 3499 in USA |
| Distribution | Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ. |
| Initiated | 2013-04-04 |
| Classified | 2013-05-24 |
| Terminated | 2014-04-16 |
| Recall number | Z-1403-2013 |
| 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, Inc. (Z-1403-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65067/
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