iCup Dx14 Drug Screen Cup(AMT recall: Labeling Error
iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection…
Why was iCup Dx14 Drug Screen Cup(AMT recalled?
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
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?
ALL Lots Within Expiry
- Product
- iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection…
- Recalling firm
- Ameditech Inc
- Quantity
- 136,925 units
- Distribution
- US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
- Recall date
- October 7, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)