[Recalled] NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concen
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screenin |
|---|---|
| Brand / manufacturer | Perkinelmer |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0688-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 26 November 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
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 Perkinelmer
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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