Alere Cholestech LDX Analyzer — Class II medical device recall Z-2475-2019
Terminated recall by Alere San Diego, Inc., reported 2019-09-11, distributed nationwide. The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being
| Recall number | Z-2475-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2019-02-15 |
| Classified | 2019-09-05 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2023-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 186 analyzer |
| Serial numbers | AA182949, AA183401, AA183418, AA183549, AA183707, AA183861, AA184017, AA184030, AA184039, AA184067, AA184070, AA184094, AA184267, AA184269, AA184270, AA184272, AA184273, AA184278, AA184279, AA184280, AA184281, AA184283, AA184284, AA184285, AA184287 and 161 more |
| Model numbers | 14-874 |
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.
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-2475-2019. 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.