FDA Medical Device Recalls (openFDA)
Ameditech Inc: 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 elevated levels of specific drugs in urine
- Recall number
- Z-3084-2017
- Recalling firm
- Ameditech Inc
- Product
- 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 elevated levels of specific drugs in urine
- Status
- Terminated
- Initiated
- 2017-06-26
- Posted
- not on file
- Terminated
- 2019-08-06
- Reason
- 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.
- Root cause
- Labeling Change Control
- Action
- Ameditech, Inc. sent an Medical Device Labeling Correction letter to all affected consignees. Remaining product at the firm was quarantined and will be scrapped. Consignees will be notified of the labeling error with a correction notification. The kit label has been corrected and is available for future product. The firm plans to conduct effectiveness checks based upon receipt of the Label Correction notification by consignees. Firm indicates that no customer action is required, so no formal reply from distributors is necessary. Customers who have not had confirmed receipt of correction notification will be telephoned. For questions regarding this recall call 858-805-3607.
- Quantity
- 263Kits
- Distribution
- Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
- Lot, serial or model codes
- P/N IS10-DX; Lot No. U0731
- 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