Class II — Advance Dx, Inc.
| Recalling firm | Advance Dx, Inc. |
|---|---|
| Registered facility | Advance Dx, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to high glucose test results when using the blood collection cards. |
| Product | 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) Technology BLOOD COLLECTION INSTRUCTIONS |
| Quantity | 179,750 cards |
| Distribution | U.S. Nationwide distribution in the states of MD and NC. |
| Initiated | 2021-07-06 |
| Classified | 2021-08-10 |
| Terminated | 2023-08-22 |
| Recall number | Z-2237-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Advance Dx, Inc. (Z-2237-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88281/
Alerts for Advance Dx, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.