Drug recall
PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare…
FDA recall event 65067 · Class II · Polymer Technology Systems, Inc.
Key facts
| Event ID | 65067 |
|---|---|
| Recall numbers | Z-1403-2013 |
| Recalling firm | Polymer Technology Systems, Inc. |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 4, 2013 |
| Report date | Jun 5, 2013 |
| Termination date | Apr 16, 2014 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 3002698769 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: