Recall Z-3041-2020
Ameditech Inc · initiated August 18, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "
Codes / lots: ALL Lots Within Expiry
Reason for recall
XXX
FDA-determined cause: Process control
Action taken
A Field Corrective Action Notice letter was sent to affected consignees. The Customer notifications commenced on 19-Aug-2020. The consignees are requested to return all non-expired product in their possession to the recalling firm. Method of Notification, 1st contact: Written field corrective action notification letters will be sent via certified mail with delivery tracking to each consignee along with a pre-paid return label to return any product remaining in stock. 2nd & 3rd contact: Telephone, follow up email, or written mail communication will be used as necessary.
Details
- Recall number
- Z-3041-2020
- Initiated
- August 18, 2020
- Terminated
- September 30, 2024
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Quantity
- 1,325 units
- Distribution
- US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
- Recalling firm
- Ameditech Inc, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3029-2020 Class II | Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3030-2020 Class II | Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX /…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3031-2020 Class II | Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup Dx…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3032-2020 Class II | CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3033-2020 Class II | Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3034-2020 Class II | Fastect II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3035-2020 Class II | Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3036-2020 Class II | ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3037-2020 Class II | MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3038-2020 Class II | MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3039-2020 Class II | Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup"…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3040-2020 Class II | iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup"…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3042-2020 Class II | ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3043-2020 Class II | QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox Drug Screen…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3044-2020 Class II | TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3045-2020 Class II | ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup Drug Screen Cup…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3046-2020 Class II | First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3047-2020 Class II | First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3048-2020 Class II | First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3049-2020 Class II | First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3050-2020 Class II | First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |
| Z-3051-2020 Class II | Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | 08/18/2020Terminated |