Product Recalls & Refunds Online / National

Alere San Diego, Inc.: The Cholestech LDX¿ System combines enzymatic

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: 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).. Recalled by Alere San Diego, Inc.. 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. Classification (Class II — potential health ris

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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