[Recalled] ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET500+MTD300+OPI300 NO |
|---|---|
| Brand / manufacturer | Ameditech Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-3036-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 18 August 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
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 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.