Z-0311-2016Class II

iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No...

Name: Z-0311-2016 iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No...
Creator: Ameditech Inc
Published: 2015-10-20
License: https://open.fda.gov/license/

Ameditech, Inc. / initiated 2015-10-20 / Terminated / root cause: manufacturing process

FDA source

Ameditech Inc began a recall of iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No... on 2015-10-20. FDA classified it as Class II and gives the reason as "Ameditech is recalling drug abuse tests because they have shown reduced reactivity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0311-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-20
Posted: 2015-11-18
Terminated: 2016-11-09
Recalling firm: Ameditech, Inc.
Product: iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Product code: JXM Enzyme Immunoassay, Benzodiazepine
Reason for recall: Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ameditech Inc. sent an Urgent Medical Device Recall Letter to al affected customers on October 20, 2015, to inform them that Ameditech is recalling affected lots of Ameditech's Drugs of Abuse Tests because they have shown reduced reactivity for up to three of the nineteen Benzodiazepine (BZO) compounds. The letter informs customers of the actions to be taken. Customers were instructed to complete and return the customer verification form to (858) 677-0243 or scan and email to [email protected]. For questions regarding this recall call 858-535-1968.
Quantity in commerce: 27,638 units
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia.
Product codes and lots: 141210 141425 141561 141870 141994 142126 143608 144152 144218 145067 150105 150167 151215 150976 141844 141929 142258 142314 143606 144511 145058 145059 150549 150867 150919 150920 151179 151190 151255 151338 151476 144377 150101 150285 150420 151161 151399 151696 144209 144463 150018 150107 150690 150883 141492 141519 141552 141726

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0311-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0298-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0299-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0300-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0301-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0302-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0303-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0304-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0305-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0306-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0307-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0308-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0309-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0310-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0311-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0312-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0313-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0314-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0315-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0316-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0317-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18

Product code JXM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)