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 sam
Check against the official notice below — it lists the full affected range.
The Cholestech LDX System's cholesterol test cassettes are subject to a recall because the package insert requires updating with new information about bilirubin interference. Testing has determined that blood samples containing bilirubin at levels above 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated) can produce inaccurate results, specifically resulting in low recovery readings for triglycerides and HDL cholesterol. The affected cassettes were distributed across numerous U.S. states and international locations, with approximately 436,990 units involved across multiple lot and part numbers.
The source document does not specify what action affected consumers or healthcare providers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
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 Quantity: 436,990 Lot/code info: All lots of Part/UDI-DI: 10-991/00893038002654, 99021/00899722002344, 14-531/04571226470831, 10-990/00893038002647, 10-989/00893038002630, 10-987/00893038002616
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.