FDA Device recall Z-1403-2013
PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals wit…
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals wit… by Polymer Technology Systems, citing internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1403-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-04 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Polymer Technology Systems |
| Distribution | US |
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
Reason
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
Identifiers
| code_info | U1117 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2020-03-11 · Polymer Technology Systems - PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems - PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems
All Polymer Technology Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1403-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.