Device recall: 1 Step 12 Panel Cup, Item No. NBCA-12M-W

FDA enforcement event 72651 · Class III · initiated 16 Nov 2015 · status Terminated · terminated 9 Nov 2016

DeviceVoluntary: Firm initiated59 product recordsSan Diego, CA

Ameditech Inc (San Diego, CA) initiated this device recall on 16 Nov 2015; FDA lists 59 product records under event 72651, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 9 Nov 2016. Initiation: voluntary: firm initiated. Ameditech Inc has 8 enforcement events on this register, with a median of 3 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Ameditech Inc, San Diego, CA.

Reason for recall

"Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide."

Distribution

"Nationwide Distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0484-2016	1 Step 12 Panel Cup, Item No. NBCA-12M-W	1,377 kits	Class III	Terminated	30 Dec 2015
Z-0485-2016	10-Panel Pipette Drug Screen, Item No. PSP-10M	240 kits	Class III	Terminated	30 Dec 2015
Z-0486-2016	11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA	40 kits	Class III	Terminated	30 Dec 2015
Z-0487-2016	11 Panel Card (OPI 300) w/Adult, Item No. 71125AA	50 kits	Class III	Terminated	30 Dec 2015
Z-0488-2016	12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.	858 kits	Class III	Terminated	30 Dec 2015
Z-0489-2016	6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP	3,603 kits	Class III	Terminated	30 Dec 2015
Z-0490-2016	BZO Strip Dip Card (300ng/ml)*, Item No. 100170	31,472 kits	Class III	Terminated	30 Dec 2015
Z-0491-2016	CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5	10,320 kits	Class III	Terminated	30 Dec 2015
Z-0492-2016	DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5	1,907 kits	Class III	Terminated	30 Dec 2015
Z-0493-2016	DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D	340 kits	Class III	Terminated	30 Dec 2015
Z-0494-2016	DrugSmart 11 Test Cup, Item No. 61127D	320 kits	Class III	Terminated	30 Dec 2015
Z-0495-2016	DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D	160 kits	Class III	Terminated	30 Dec 2015
Z-0496-2016	DrugSmart 9 Test Cup (BUP), Item No. 60960D	320 kits	Class III	Terminated	30 Dec 2015
Z-0497-2016	DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D	272 units	Class III	Terminated	30 Dec 2015
Z-0498-2016	DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D	60 kits	Class III	Terminated	30 Dec 2015
Z-0499-2016	DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D	120 kits	Class III	Terminated	30 Dec 2015
Z-0500-2016	DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D	80 units	Class III	Terminated	30 Dec 2015
Z-0501-2016	EDI BZO Uncut Sheet - Cup*, Item No. 160170	45,584 kits	Class III	Terminated	30 Dec 2015
Z-0502-2016	iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142	6,304 kits	Class III	Terminated	30 Dec 2015
Z-0503-2016	iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131	26 units	Class III	Terminated	30 Dec 2015
Z-0504-2016	iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023	9,566 kits	Class III	Terminated	30 Dec 2015
Z-0505-2016	iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013	2,085 kits	Class III	Terminated	30 Dec 2015
Z-0506-2016	iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016	8,290 units	Class III	Terminated	30 Dec 2015
Z-0507-2016	Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5	320 kits	Class III	Terminated	30 Dec 2015
Z-0508-2016	Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP	240 kits	Class III	Terminated	30 Dec 2015
Z-0509-2016	Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W	1,909 kits	Class III	Terminated	30 Dec 2015
Z-0510-2016	Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP	200 kits	Class III	Terminated	30 Dec 2015
Z-0511-2016	ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3	2,693 kits	Class III	Terminated	30 Dec 2015
Z-0512-2016	ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P	60 kits	Class III	Terminated	30 Dec 2015
Z-0513-2016	Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W	144 kits	Class III	Terminated	30 Dec 2015
Z-0514-2016	Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU	4,646 kits	Class III	Terminated	30 Dec 2015
Z-0515-2016	ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX	160 kits	Class III	Terminated	30 Dec 2015
Z-0516-2016	ProScreen 10 Panel Cup, Item No. PSCup-10M	3,411 kits	Class III	Terminated	30 Dec 2015
Z-0517-2016	ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM	96 kits	Class III	Terminated	30 Dec 2015
Z-0518-2016	ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300	2,452 kits	Class III	Terminated	30 Dec 2015
Z-0519-2016	ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.	1,989 kits	Class III	Terminated	30 Dec 2015
Z-0520-2016	ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU	636 kits	Class III	Terminated	30 Dec 2015
Z-0521-2016	ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M	1200 kits	Class III	Terminated	30 Dec 2015
Z-0522-2016	ProScreen 12 Panel Dip Card, Item No. PSD-12BUP	60 kits	Class III	Terminated	30 Dec 2015
Z-0523-2016	ProScreen 5 Panel Dip Card, Item No. PSD-12BUP	338 kits	Class III	Terminated	30 Dec 2015
Z-0524-2016	ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300	120 kits	Class III	Terminated	30 Dec 2015
Z-0525-2016	ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU	60 kits	Class III	Terminated	30 Dec 2015
Z-0526-2016	ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU	7,805 kits	Class III	Terminated	30 Dec 2015
Z-0527-2016	ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,	2,675 kits	Class III	Terminated	30 Dec 2015
Z-0528-2016	ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU	168 kits	Class III	Terminated	30 Dec 2015
Z-0529-2016	ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3	200 kits	Class III	Terminated	30 Dec 2015
Z-0530-2016	ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M	567 kits	Class III	Terminated	30 Dec 2015
Z-0531-2016	ProScreen 8 Panel Dip Card, Item No. PSD-8P	249 kits	Class III	Terminated	30 Dec 2015
Z-0532-2016	ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300	82 kits	Class III	Terminated	30 Dec 2015
Z-0533-2016	ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300	N/A	Class III	Terminated	30 Dec 2015
Z-0534-2016	ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300	3 kits	Class III	Terminated	30 Dec 2015
Z-0535-2016	ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W	2,136 kits	Class III	Terminated	30 Dec 2015
Z-0536-2016	ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W	492 kits	Class III	Terminated	30 Dec 2015
Z-0537-2016	ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W	129 kits	Class III	Terminated	30 Dec 2015
Z-0538-2016	ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W	1,680 kits	Class III	Terminated	30 Dec 2015
Z-0539-2016	ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W	743 kits	Class III	Terminated	30 Dec 2015
Z-0540-2016	RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA	80 kits	Class III	Terminated	30 Dec 2015
Z-0541-2016	THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU	300 kits	Class III	Terminated	30 Dec 2015
Z-0542-2016	THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU	100 kits	Class III	Terminated	30 Dec 2015

Context

4%of 2015 device events are Class III1,153 events that year

59product records in this eventfirm median: 3

8events on this register for the firm

Other enforcement events for Ameditech Inc

Initiated	Product (first record)	Type	Class	Records
18 Aug 2020	Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Ca	Device	Class II	23
15 Feb 2019	QuickTox 5 Panel Drug Screen DipCard	Device	Class III	1
15 Dec 2017	Alere iScreen Dx Urine Drug Screen Card	Device	Class III	1
30 Sep 2017	Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detect	Device	Class III	1
26 Jun 2017	Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 I	Device	Class III	1
20 Oct 2015	1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detect	Device	Class II	20
23 Sep 2014	ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoa	Device	Class II	3

All 8 events for Ameditech Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide Distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 9 Nov 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.