Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology Recalled by Alere San Diego, Inc. Due to Cholesterol test cassettes package insert is to be...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alere San Diego, Inc. directly.
Affected Products
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
Quantity: 436,990
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed to 31 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MN, MO, NE, NV, NY, NC, OH, OK, PA, RI, SC, TN, TX, VA
About Alere San Diego, Inc.
Alere San Diego, Inc. has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report