[Recalled] CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5 — Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for… | FDA 2015-11-16
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5 |
|---|---|
| Brand / manufacturer | Ameditech Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0491-2016 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 16 November 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.
This Class III 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 Ameditech 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.