[Recalled] CHOL+HDL+GLU test strips, REF 2412 — Some lots of test strips do not fit tightly into the optical block, and may fal… | FDA 2019-01-16
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | CHOL+HDL+GLU test strips, REF 2412 |
|---|---|
| Brand / manufacturer | Polymer Technology Systems, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1373-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 16 January 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
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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