Recall Z-3038-2020
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
MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G.", MTPA-6MBAU/ "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G."
Codes / lots: ALL Lots Within Expiry
Reason for recall
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.
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-3038-2020
- Initiated
- August 18, 2020
- Terminated
- September 30, 2024
- Product code
- DKC – Alcohol Control Materials
- Quantity
- 12, 100 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-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-3041-2020 Class II | Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE…XXX | 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 |