Alere iScreen Dx Urine Drug Screen Card recall
Alere iScreen Dx Urine Drug Screen Card
Why was Alere iScreen Dx Urine Drug Screen Card recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.
- Product
- Alere iScreen Dx Urine Drug Screen Card
- Recalling firm
- Ameditech Inc
- Quantity
- 828 kits (20,700 devices)
- Distribution
- Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
- Recall date
- May 9, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)