Alere iScreen Dx Urine Drug Screen Card recall
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen…
Why was Alere iScreen Dx Urine Drug Screen Card recalled?
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.
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?
P/N IS10-DX; Lot No. U0731
- 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…
- Recalling firm
- Ameditech Inc
- Quantity
- 263Kits
- Distribution
- Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
- Recall date
- September 6, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)