[Recalled] Phadia 1000 Instrument, Article Number 12-3800-01. — The "Retry" command does not function properly which could cause a shortage of… | FDA 2017-07-05
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Phadia 1000 Instrument, Article Number 12-3800-01. |
|---|---|
| Brand / manufacturer | Phadia US Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0387-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 July 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
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 Phadia US 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.