[Recalled] PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers — This lot of test strips is showing an under-recovery when tested against a refe… | FDA 2016-03-15
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers |
|---|---|
| Brand / manufacturer | Polymer Technology Systems, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0741-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 15 March 2016 |
| EAN / barcode | 00381932412018 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: This lot of test strips is showing an under-recovery when tested against a reference method.
This Class II 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.
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.
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