PTS PANELS — Class II medical device recall Z-1403-2013
Terminated recall by Polymer Technology Systems, Inc., reported 2013-06-05, distributed nationwide. Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This co
| Recall number | Z-1403-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Polymer Technology Systems, Inc., Indianapolis, IN, United States |
| Recall initiated | 2013-04-04 |
| Classified | 2013-05-24 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, GB |
| Quantity | 7,048 total |
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 for recall
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1403-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.