Alere recalls Cholestech LDX cholesterol test cassettes that may give inaccurate results when bilirubin levels exceed certain thresholds. Update package insert with new interference information to avoid false low HDL and triglyceride readings.
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).
Alere is recalling specific Cholestech LDX cholesterol test cassettes because they can produce inaccurate results when samples contain high bilirubin levels. This could lead to incorrect cholesterol readings if not addressed.
The cassettes may give false low readings for HDL cholesterol and triglycerides when bilirubin concentrations exceed 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated). This happens because bilirubin interferes with the test chemistry.
People using Cholestech LDX cassettes for cholesterol testing at home with whole blood samples. Those with high bilirubin levels (e.g., from liver conditions) are most at risk of inaccurate results.
Check for cassettes labeled with part numbers 10-991, 99021, 14-531, 10-990, 10-989, or 10-987. These were sold with specific lot numbers listed in the recall notice.
Look for part numbers 10-991, 99021, 14-531, 10-990, 10-989, or 10-987 on the cassette packaging.
The recall is because samples with high bilirubin levels can cause inaccurate cholesterol test results, specifically low readings for HDL and triglycerides.
No, but you should check if your cassettes have the listed part numbers and update the package insert with the new bilirubin interference information.
Check the cassette labels for the part numbers listed in the recall. If you have them, update the package insert with the new bilirubin interference information to avoid inaccurate results.
We’ve drafted a message you can send Alere to request your refund or repair — edit it as you like.
Subject: Recall Z-1508-2022 — Alere Alere Hello, I own a Alere that is covered by recall Z-1508-2022 from Alere. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
