[Recalled] PTS Panels CHOL+GLU Test Strips (REF 1765) — Incorrect instructions for use were packaged into the final product | FDA 2022-08-16
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | PTS Panels CHOL+GLU Test Strips (REF 1765) |
|---|---|
| Brand / manufacturer | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1741-2022 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 16 August 2022 |
| EAN / barcode | 00381931765016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Incorrect instructions for use were packaged into the final product.
This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.