# FDA recall Z-3138-2017

> **Kamiya Biomedical Company, LLC** · Class II · device recall initiated 2017-07-19.

## Product

K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD  The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use

## Reason for recall

The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.

## Distribution

Worldwide Distribution - US including FL, CA, WA, OH, IA, IL, NJ, NY, NC, MA, TX, CT, MD, VA, Internationally to TN, Czech Republic, Taiwan, Dominican Republic, Switzerland, China, and Jamaica

## Key facts

- **Recall number:** Z-3138-2017
- **Recalling firm:** Kamiya Biomedical Company, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-19
- **Report date:** 2017-09-27
- **Termination date:** 2018-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tukwila, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3138-2017

## Citation

> AI Analytics. FDA recall Z-3138-2017. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-3138-2017. Source: US FDA. Licensed CC0.

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