FDA Medical Device Recalls (openFDA)
Ameditech Inc: Alere iScreen Dx Urine Drug Screen Card
- Recall number
- Z-1542-2018
- Recalling firm
- Ameditech Inc
- Product
- Alere iScreen Dx Urine Drug Screen Card
- Status
- Terminated
- Initiated
- 2017-12-15
- Posted
- not on file
- Terminated
- 2019-02-11
- Reason
- The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
- Root cause
- Labeling Change Control
- Action
- Customers were notified on about 12/15/2017. Instructions included to become aware of the recall so as to relay the information to customers with questions.
- Quantity
- 828 kits (20,700 devices)
- Distribution
- Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
- Lot, serial or model codes
- Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.
- 510(k) numbers
- ["K022355"]
- PMA numbers
- not on file
- Product code
- LFH
- Firm FEI
- 3003789989
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28