Scottsdale, AZ, United States
Advance Dx, Inc. recalls
1 recall recorded since 2018, most recently on 6 July 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 6 July 2021
- Terminated
- 22 August 2023
- Reason
- Due to high glucose test results when using the blood collection cards.
- Distribution
- U.S. Nationwide distribution in the states of MD and NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2237-2021
- Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) T
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.