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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-3031-2020 - Alere iCup Drug Detection (AMT Item Number/ AMT Description):
I-DXA-10/ "Alere" iCup® Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC
Bl, Cr, Ni, pH, SG",
I-DXA-13B...
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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Z-3030-2020 - Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description):
X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test
12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+ME...
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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Z-3029-2020 - Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description):
X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)",
X11-IS1 BAR-DX /"Alere iScree...
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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Z-3032-2020 - CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description):
X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dipstick Test
BUP10,
X07-CLIA-SDDT-25 / "CLIA Waived" Inc. Single Drug Dipstick...
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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Z-3033-2020 - Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description):
164-DXA14 /"Consult Diagnostics
DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS
AMP500/BAR/BUPG/BZO/COC150/MDMA...
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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Z-3051-2020 - Drug Screening Component: Uncut Sheets
Part Number/ Description/ LOT Number
100163/ EDI OPI (300) Uncut Sheet-Card /187876,
100195/ EDI PPX Uncut Sheet-Card/ 187877,
160130/ EDI COC Uncut Sheet-Cu...
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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Z-3034-2020 - Fastect® II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description):
MF25/ "Fastect® II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect® II Drug Sc...
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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Z-3046-2020 - First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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Z-3047-2020 - First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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Z-3048-2020 - First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
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2
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09/30/2020
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FEI # 3003789989 Ameditech Inc
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