[Recalled] H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054 — Products shipped to US locations that do not have approved applications for PMA… | FDA 2014-03-04
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054 |
|---|---|
| Brand / manufacturer | LumiQuick Diagnostics Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1342-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 March 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
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 →
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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.