# FDA recall Z-2475-2019

> **Alere San Diego, Inc.** · Class II · device recall initiated 2019-02-15.

## Product

Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX¿ Analyzer.

## Reason for recall

The polarity of the output of  power supply was reversed.  Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.

## Distribution

US Nationwide distribution in the states of AK, A, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY< OH, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI.    No OUS consignees

## Key facts

- **Recall number:** Z-2475-2019
- **Recalling firm:** Alere San Diego, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-15
- **Report date:** 2019-09-11
- **Termination date:** 2023-12-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2475-2019

## Citation

> AI Analytics. FDA recall Z-2475-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2475-2019. Source: US FDA. Licensed CC0.

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