# FDA recall Z-1508-2022

> **Alere San Diego, Inc.** · Class II · device recall initiated 2022-06-24.

## Product

The Cholestech LDX¿ System combines enzymatic methodology and solidphase  technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples  used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX¿ cassette.    Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531;  Cholestech LDX TC HDL GLU Cassette/10-990;  Cholestech LDX Lipid Profile Cassette/10-989;  Cholestech LDX TC HDL Cassette/10-987

## Reason for recall

Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).

## Distribution

US: IL, NV, FL, LA, CA, MA, MN, NC, AK, NE, TX, PA, RI, SC, TN, OK, KY, GA, NY, MO, CO, AZ, OH, HI, VA, KS, IN, AL.    OUS: GB, ZA, NO, NL, FI, IE, IQ, IT, CH, DE, ES, HU, SI, NA, PT, IS, NG, PL, CY, TN, BH, ID, MY, AU, SG, JP, IN, BD, KR, HK, BR, CO, AR, CA

## Key facts

- **Recall number:** Z-1508-2022
- **Recalling firm:** Alere San Diego, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-24
- **Report date:** 2022-08-17

- **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-1508-2022

## Citation

> AI Analytics. FDA recall Z-1508-2022. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1508-2022. Source: US FDA. Licensed CC0.

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