First Check 14 Panel Drug Cup recall: Labeling Error
First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
Why was First Check 14 Panel Drug Cup 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
- First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
- Recalling firm
- Ameditech Inc
- Quantity
- 47,005 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)