Alere San Diego, Inc. 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Alere San Diego, Inc.
Lot Codes / Batch Numbers
All lots of Part/UDI-DI: 10-991/00893038002654, 99021/00899722002344, 14-531/04571226470831, 10-990/00893038002647, 10-989/00893038002630, 10-987/00893038002616
Products Sold
All lots of Part/UDI-DI: 10-991/00893038002654, 99021/00899722002344, 14-531/04571226470831, 10-990/00893038002647, 10-989/00893038002630, 10-987/00893038002616
Alere San Diego, Inc. is recalling The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total due to Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
On 6/24/22, correction notices were mailed and emailed to customers who were asked to take the following actions: 1) Test results from patients with bilirubin levels above 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated) should be verified using another test method. 2) Complete and return the Customer Reply Form. 3) If you have forwarded the products listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 4) Retain this letter for your laboratory records. Customers with questions are encouraged to contact Technical Service at 877-308-8289.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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
Page updated: Jan 10, 2026