FDA (Devices) recall action 86335

Ameditech Inc recalled 23 products on 2020-10-07

The FDA (Devices) publishes a recall like this one as 23 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 23 pages.

Products: 23
Announced: 2020-10-07
Critical: 0
Units: 4,494,695

Why these products were recalled

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.

XXX

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–23 of 23

HighFDA (Devices)··2020-10-07
Ameditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures
Ameditech is recalling ImmuTest Drugs of Abuse Cups because they failed to consistently detect all compounds at labeled levels.
Product
ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET5
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Fastect II Drug Screen Dipstick Tests Recalled for Performance Failures
Ameditech is recalling Fastect II Drug Screen Dipstick Tests because they failed to consistently detect compounds at labeled levels.
Product
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 Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300", MF20/ "Fas
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Noble 1 Step+ Cup Recalled for Inconsistent Performance
Ameditech is recalling Noble 1 Step+ Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.
Product
Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl, S.G. Finished Devices", NBCA-14A-PP/"Noble 1 Step + Cup" (THC50/COC150
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Recalls One Step + DOA Cup Due to Performance Failures
Ameditech is recalling 31,800 units of the Henry Schein One Step + DOA Cup because the immunoassay enzymes failed performance tests, resulting in inconsistent detection of compounds.
Product
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
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0 states
HighFDA (Devices)··2020-10-07
Ameditech MicroTox Immunoassay Enzymes Recalled for Performance Failures
Ameditech Inc is recalling MicroTox immunoassay enzymes because they failed to consistently detect compounds at labeled levels.
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."
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech iCup Dx14 Drug Screen Cup Recalled for Performance Failures
Ameditech is recalling iCup Dx14 Drug Screen Cups because immunoassay enzymes failed performance tests, causing inconsistent detection of compounds.
Product
iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni, pH,
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Recalls First Check 14 Panel Drug Cups Due to Performance Failures
Ameditech is recalling 47,005 units of First Check 14 Panel Drug Cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
Product
First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
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Distribution
0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Recalls Alere iScreen Single Drug Detection Dip Cards
Ameditech is recalling Alere iScreen Single Drug Detection dip cards because they may fail to consistently detect certain compounds at labeled levels.
Product
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 iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-D
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0 states
HighFDA (Devices)··2020-10-07
Ameditech Recalls Alere iScreen Multi Drug Detection Tests
Ameditech is recalling Alere iScreen Multi Drug Detection tests because they may fail to consistently detect all compounds at labeled levels.
Product
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+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS12-DX / "Alere iScreen" Dx
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0 states
HighFDA (Devices)··2020-10-07
Ameditech Recalls ProScreen Drugs of Abuse Tests Due to Performance Failures
Ameditech is recalling ProScreen Drugs of Abuse Tests because immunoassay enzymes failed performance standards, causing inconsistent detection of compounds.
Product
ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET
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0 states
HighFDA (Devices)··2020-10-07
Ameditech Recalls QuickTox Drug Screen DipCards Due to Performance Failures
Ameditech is recalling QuickTox Drug Screen DipCards because immunoassay enzymes failed performance tests, meaning the products may not consistently detect all compounds at labeled levels.
Product
QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+MDMA500", QT88/ "QuickTox¿ Drug Screen Dipcard 12 Drug Detection: COC300+OPI300+MET500+THC50
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Recalls Consult Diagnostics Drugs Abuse Test Cups
Ameditech Inc is recalling 31,600 units of Consult Diagnostics Drugs Abuse Test Cups because immunoassay enzymes failed performance tests, leading to inconsistent detection of compounds.
Product
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/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech ToxCup Drug Screen Cups Recalled for Performance Failures
Ameditech is recalling ToxCup Drug Screen Cups because they may fail to consistently detect all substances at labeled levels.
Product
ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 Adulteration Screen for CR - NI - PH - BL - S.G.", DT14/ "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Recalls First Check 7 Panel Drug Cups Due to Performance Failures
Ameditech is recalling 99,900 units of First Check 7 Panel Drug Cups because the products failed to consistently detect all compounds at labeled levels.
Product
First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Recalls TDDA Drugs of Abuse Cups Due to Performance Failures
Ameditech Inc is recalling TDDA Drugs of Abuse Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.
Product
TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G."
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Recalls First Check 2 Panel Drug Cups Due to Performance Failures
Ameditech is recalling 41,340 units of First Check 2 Panel Drug Cups because the products failed to consistently detect compounds at labeled levels.
Product
First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Drug Screening Components Recalled for Performance Failures
Ameditech Inc is recalling specific drug screening components because they failed to consistently detect compounds at labeled levels.
Product
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-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Shee
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0 states
HighFDA (Devices)··2020-10-07
Ameditech Recalls First Check 4 Panel Drug Cups Due to Performance Failures
Ameditech Inc is recalling 537,120 units of First Check 4 Panel Drug Cups because they may fail to consistently detect all compounds at labeled levels.
Product
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
Category
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Recalls Alere iCup Drug Detection Cups Due to Performance Failures
Ameditech Inc is recalling Alere iCup Drug Detection cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
Product
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/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/
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0 states
ModerateFDA (Devices)··2020-10-07
Ameditech Recalls Oratect III Oral Fluid Drug Screen Devices
Ameditech Inc is voluntarily recalling 1,325 units of Oratect III Oral Fluid Drug Screen Devices due to a Class II safety concern.
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 "
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0 states
HighFDA (Devices)··2020-10-07
Ameditech MicroScreen Immunoassay Recalled for Inconsistent Detection Performance
Ameditech Inc is recalling 23,000 MicroScreen immunoassay units because they failed to consistently detect compounds at labeled levels.
Product
MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "
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0 states
HighFDA (Devices)··2020-10-07
Ameditech Recalls First Check 1 Panel Drug Cup Due to Performance Failures
Ameditech Inc is recalling First Check 1 Panel Drug Cup (THC) units because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
Product
First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
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0 states
HighFDA (Devices)··2020-10-07
Ameditech Recalls CLIA Waived Rapid Drug Tests for Performance Failures
Ameditech Inc is recalling various CLIA Waived Rapid Drug Tests because immunoassay enzymes failed performance standards, preventing consistent detection of compounds.
Product
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 Test BUP10, X07-CLIA-SDDT-13 /"CLIA Waived" Inc. Single Drug Dipstick Test
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0 states