Recall Z-0509-2016
Ameditech Inc · initiated November 16, 2015
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
Codes / lots: 141758 141921 142657 143178 143581 144563 151337 152240 152782 153154 153401
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0509-2016
- Initiated
- November 16, 2015
- Terminated
- November 9, 2016
- Product code
- JXM – Enzyme Immunoassay, Benzodiazepine
- Quantity
- 1,909 kits
- Distribution
- Nationwide Distribution.
- Recalling firm
- Ameditech Inc, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0484-2016 Class III | 1 Step 12 Panel Cup, Item No. NBCA-12M-WAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0485-2016 Class III | 10-Panel Pipette Drug Screen, Item No. PSP-10MAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0486-2016 Class III | 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AAAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0487-2016 Class III | 11 Panel Card (OPI 300) w/Adult, Item No. 71125AAAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0488-2016 Class III | 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX…Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0489-2016 Class III | 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUPAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0490-2016 Class III | BZO Strip Dip Card (300ng/ml)*, Item No. 100170Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0491-2016 Class III | CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0492-2016 Class III | DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0493-2016 Class III | DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020DAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0494-2016 Class III | DrugSmart 11 Test Cup, Item No. 61127DAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0495-2016 Class III | DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup…Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0496-2016 Class III | DrugSmart 9 Test Cup (BUP), Item No. 60960DAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0497-2016 Class III | DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015DAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0498-2016 Class III | DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600DAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0499-2016 Class III | DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600DAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0500-2016 Class III | DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520DAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0501-2016 Class III | EDI BZO Uncut Sheet - Cup*, Item No. 160170Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0502-2016 Class III | iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0503-2016 Class III | iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0504-2016 Class III | iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0505-2016 Class III | iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0506-2016 Class III | iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0507-2016 Class III | Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0508-2016 Class III | Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OPAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0510-2016 Class III | Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OPAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0511-2016 Class III | ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0512-2016 Class III | ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7PAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0513-2016 Class III | Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-WAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |
| Z-0514-2016 Class III | Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAUAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen… | 11/16/2015Terminated |