Recall Z-0497-2016 ยท JXM Enzyme Immunoassay, Benzodiazepine
Ameditech Inc
DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D
| Date | Nov 16, 2015 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at amt.fieldaction@alere.com. |
| Quantity | 272 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052115 | FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY First Check Diagnostics, LLC, Dec 29, 2005 |
| K113046 | AMEDITECH IMMUTEST MILTI-DRUG SCREEN Ameditech, Inc., Nov 10, 2011 |
| K113501 | AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) Ameditech, Inc., Dec 5, 2011 |