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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 8 of 8 Results
510(K) Number: K122633
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Product Description
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FDA Recall
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Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup® Dx 10 Drug ... 2 09/30/2020 FEI # 3003789989
Ameditech Inc
CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" ... 2 09/30/2020 FEI # 3003789989
Ameditech Inc
Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult ... 2 09/30/2020 FEI # 3003789989
Ameditech Inc
First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B 2 09/30/2020 FEI # 3003789989
Ameditech Inc
Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC... 2 09/30/2020 FEI # 3003789989
Ameditech Inc
iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Dru... 2 09/30/2020 FEI # 3003789989
Ameditech Inc
ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup® Drug Screen Cup COC3... 2 09/30/2020 FEI # 3003789989
Ameditech Inc
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneS... 2 09/30/2020 FEI # 3003789989
Ameditech Inc
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