Alere Cholestech LDX recallZ-1508-2022 · Alere San Diego, Inc. · initiated Jun 24, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alere San Diego, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Device Design
What the company is doing
On 6/24/22, correction notices were mailed and emailed to customers who were asked to take the following actions: 1) Test results from patients with bilirubin levels above 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated) should be verified using another test method. 2) Complete and return the Customer Reply Form. 3) If you have forwarded the products listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 4) Retain this letter for your laboratory records. Customers with questions are encouraged to contact Technical Service at 877-308-8289.
Recall details
- Recall number
- Z-1508-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 24, 2022
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- 436,990
- Product code
- CGA
- FDA submissions
- K120615
- 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
Product description
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 sample is applied to an Cholestech LDX cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid Profile Cassette/10-989; Cholestech LDX TC HDL Cassette/10-987
Code information (models, lots, serial numbers)
All lots of Part/UDI-DI: 10-991/00893038002654, 99021/00899722002344, 14-531/04571226470831, 10-990/00893038002647, 10-989/00893038002630, 10-987/00893038002616
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- Alere Cholestech LDX® 10-991Alere San Diego, Inc. · Glucose Oxidase, Glucose1 recall1 report
- Alere Cholestech LDX® 10-987Alere San Diego, Inc. · Enzymatic Esterase--Oxidase, Cholesterol1 recall0 reports
- Alere Cholestech LDX® 10-989Alere San Diego, Inc. · Colorimetric Method, Triglycerides1 recall0 reports
- Alere Cholestech LDX® 10-990Alere San Diego, Inc. · Glucose Oxidase, Glucose1 recall0 reports
- Alere Cholestech LDX® 99021Alere San Diego, Inc. · Glucose Oxidase, Glucose1 recall0 reports
- Alere Cholestech LDX® 14-531Alere San Diego, Inc. · Glucose Oxidase, Glucose1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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