Recall Z-0308-2016 ยท JXM Enzyme Immunoassay, Benzodiazepine
Ameditech Inc
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug str
| Date | Oct 20, 2015 |
| Status | Terminated |
| Reason | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. |
| Root cause | Nonconforming Material/Component |
| Action | Ameditech Inc. sent an Urgent Medical Device Recall Letter to al affected customers on October 20, 2015, to inform them that Ameditech is recalling affected lots of Ameditech's Drugs of Abuse Tests because they have shown reduced reactivity for up to three of the nineteen Benzodiazepine (BZO) compounds. The letter informs customers of the actions to be taken. Customers were instructed to complete and return the customer verification form to (858) 677-0243 or scan and email to amt.fieldaction@alere.com. For questions regarding this recall call 858-535-1968. |
| Quantity | 1220 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Australia. |
| 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 |