# FDA recall Z-1476-2024

> **Abbott Laboratories** · Class II · device recall initiated 2024-02-21.

## Product

ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

## Reason for recall

The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim.  This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.

## Distribution

Worldwide - US Nationwide distribution in the states of  AL, AR, AZ, CA, FL, GA, IL, KS, LA, MI, MO, MS, NE, NY, OH, OR, PA, TX, VA, and WI. The countries of Angola, Austria, Belarus, Belgium, Brazil, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Mali, Mexico, Morocco, Poland, Portugal, Peoples Republic of  China, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Switzerland, Taiwan, Tajikistan, Tanzania, Trinidad & Tobago, Turkey, Uganda, Uruguay, Uzbekistan, and Vietnam.

## Key facts

- **Recall number:** Z-1476-2024
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-21
- **Report date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Abbott Park, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1476-2024

## Citation

> AI Analytics. FDA recall Z-1476-2024. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1476-2024. Source: US FDA. Licensed CC0.

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