FDAJune 24, 2022device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Ongoing
Brands named
alere san diegoalerealere san
UPCs
008930380026540089972200234404571226470831008930380026470089303800263000893038002616
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCDemlar Recalls MoonSoll and Magic Chems Fuel Bottles Due to Risk of Serious Injury or Death from Flash Fire; Violates Mandatory Standard for Portable Fuel Containers and FHSA Labeling Requirements; Imported by Demlar Online Store2025-11-20
- FDAMi More snacks, Coco Bandera, 3 oz. Plastic container, 8 per container, 20 per case box2024-12-04
- USDA FSISFSIS Issues Public Health Alert for Raw Pork Chorizo Products Due to Possible Foreign Matter Contamination2024-05-02
- FDA3-ounce H-E-B Creamy Creations Ice Cream Lime/Orange Combo - 12 pack2024-04-27
- FDA3-ounce H-E-B Creamy Creations Chocolate Ice Cream-12 pk2024-04-27
- FDA3-ounce H-E-B Creamy Creations Ice Cream Homemade/Chocolate Combo -12 pack2024-04-27
- FDAAbbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 551702024-03-01
- FDAREF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 22922023-06-09
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