Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx… — Class II medical device recall Z-2237-2021
Terminated recall by Advance Dx, Inc., reported 2021-08-18, distributed nationwide. Due to high glucose test results when using the blood collection cards.
| Recall number | Z-2237-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advance Dx, Inc., Scottsdale, AZ, United States |
| Recall initiated | 2021-07-06 |
| Classified | 2021-08-10 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2023-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 179,750 cards |
| Lot numbers | PPD02102 |
| Model numbers | CMT01, CMT01/F02 |
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
Reason for recall
Due to high glucose test results when using the blood collection cards.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2237-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.