Ameditech Recalls Alere iScreen Dx Urine Drug Screen Cards for Labeling Error
Ameditech is recalling Alere iScreen Dx Urine Drug Screen Cards because the box label incorrectly lists Phencyclidine (PCP) instead of Tricyclic Antidepressants (TCA).
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 regarding the list of drug analytes.
Plain-English summary
Ameditech Inc is recalling 828 kits (20,700 devices) of the Alere iScreen Dx Urine Drug Screen Card. The recall is due to a labeling error on the kit box, which incorrectly identifies Phencyclidine (PCP) as one of the drug analytes. The label should have listed Tricyclic Antidepressants (TCA) instead.
The affected products are identified by Part No. X11-IS10-Dx and Lot Nos. 173351, 173686, 174055, and 176002. These kits were distributed domestically to Arizona, Florida, Illinois, North Dakota, Nevada, Pennsylvania, Tennessee, Texas, and Virginia.
Consumers and healthcare facilities should check their inventory for the specific part and lot numbers listed above. If the product matches the recall description, it should be removed from use and returned to the distributor or manufacturer.
The recalled product
- Product
- Alere iScreen Dx Urine Drug Screen Card
- Manufacturer
- Ameditech Inc
- Hazard
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 (5)
- Part No. X11-IS10-Dx
- Lot No. 173351
- 173686
- 174055
- 176002.
Distribution
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