Food, drugs, devices › Ameditech Inc
Device recall: Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 I
Ameditech Inc (San Diego, CA) initiated this device recall on 26 Jun 2017; FDA lists 1 product record under event 77702, 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 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 6 Aug 2019. 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
"The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly."
Distribution
"Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3084-2017 | Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect… | 263Kits | Class III | Terminated | 6 Sep 2017 |
Context
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 |
| 16 Nov 2015 | 1 Step 12 Panel Cup, Item No. NBCA-12M-W | Device | Class III | 59 |
| 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: "The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly."
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 to AZ, IL, IN, KY, NV, PA, TN, and TX"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Aug 2019. "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.