# FDA recall Z-2237-2021

> **Advance Dx, Inc.** · Class II · device recall initiated 2021-07-06.

## 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.

## Distribution

U.S. Nationwide distribution in the states of MD and NC.

## Key facts

- **Recall number:** Z-2237-2021
- **Recalling firm:** Advance Dx, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-06
- **Report date:** 2021-08-18
- **Termination date:** 2023-08-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Scottsdale, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2237-2021

## Citation

> AI Analytics. FDA recall Z-2237-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2237-2021. Source: US FDA. Licensed CC0.

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