Drug recall
PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
FDA recall event 79778 · Class II · Polymer Technology Systems, Inc.
Key facts
| Event ID | 79778 |
|---|---|
| Recall numbers | Z-1543-2018 |
| Recalling firm | Polymer Technology Systems, Inc. |
| Product type | Devices |
| Products | PTS Panels¿ CHOL+GLU Test Strips (REF 1765) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018) |
| Initiation date | Mar 14, 2018 |
| Report date | May 9, 2018 |
| Termination date | Sep 13, 2018 |
| 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: