Alere iScreen Dx Urine Drug Screen Card Recalled for Labeling Error
Ameditech Inc is recalling Alere iScreen Dx Urine Drug Screen Cards because the kit box label incorrectly identifies PCP instead of TCA as a drug analyte.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error on the outer packaging that does not affect the functionality or safety of the test device itself.
Plain-English summary
Ameditech Inc is voluntarily recalling 263 kits of the Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection. The recall is due to a labeling error on the kit box, which incorrectly identifies PCP (phencyclidine) as one of the 10 drug analytes included in the kit, whereas the correct analyte is TCA (tricyclic antidepressants).
The error is limited to the outer kit box label. The individual pouch labels, the product insert, and the test device itself are all labeled correctly. The affected product is identified by Part Number IS10-DX and Lot Number U0731.
The product was distributed nationwide to Arizona, Illinois, Indiana, Kentucky, Nevada, Pennsylvania, Tennessee, and Texas. Users should verify the lot number and part number on their kits. If the product matches the recalled lot, users should stop using the kit and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Ameditech Inc
- Hazard
- Affected units
- 263
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- P/N IS10-DX
- Lot No. U0731
Distribution
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