Lower risk Medical device recall · FDA · Published June 24, 2022

Alere Cholestech LDX System: Bilirubin Interference in Cholesterol Tests

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1508-2022Medical device Alere ›

Lower-risk 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).

Take action

Contact the company

Recalling firmAlere San Diego, Inc.9975 Summers Ridge Rd · San Diego, CA 92121-2997

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/60422-alere-cholestech-ldx-system-bilirubin-interference-in-cholesterol-tests.

Source Summary by GovInfoNow · govinfonow.com/recall/60422-alere-cholestech-ldx-system-bilirubin-interference-in-cholesterol-tests · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1508-2022

Cite this page

“Alere Cholestech LDX System: Bilirubin Interference in Cholesterol Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60422-alere-cholestech-ldx-system-bilirubin-interference-in-cholesterol-tests. Based on FDA recall #Z-1508-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1508-2022%22&limit=1).

Alere San Diego, Inc. recalled The Cholestech LDX System cassettes on June 24, 2022, according to the FDA. The hazard involves potential inaccurate test results due to bilirubin interference. Owners should update package inserts with new information.

How to tell if you have it

Brand: Alere
Product: Cholestech LDX System cassettes
Part Numbers: 10-991, 99021, 14-531, 10-990, 10-989, 10-987
Lot Codes/UDI-DI: 00893038002654, 00899722002344, 04571226470831, 00893038002647, 00893038002630, 00893038002616
Units affected: 436,990

The hazard

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).

Context

GovInfoNow's records show Alere San Diego, Inc. has had four other recalls since November 14, 2017. Other recent recalls of similar products include Beckman Coulter LDL Cholesterol Reagent May Give False High Results (December 8, 2025), Instrumentation Laboratory GEM Premier 5000 PAK: Lysing Bag Solution Risk (May 21, 2026), and Accriva Diagnostics recalls directCHECK ACT-LR blood control with incorrect labeling (April 30, 2026).

How to tell if you have this one

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.

Brand
Alere
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Cassette Labels
Look for part numbers 10-991, 99021, 14-531, 10-990, 10-989, or 10-987 on the cassette packaging.

Where it went and when

Where it was distributed

Distributed in 28 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Nebraska, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia.

Recall timeline

FDA published this recall 54 days after the firm started it.

Jun 24, 2022Firm started the recall
Aug 6, 2022FDA classified it Class II
Aug 17, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/60422-alere-cholestech-ldx-system-bilirubin-interference-in-cholesterol-tests">Alere Cholestech LDX System: Bilirubin Interference in Cholesterol Tests (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1508-2022 (June 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1508-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.