The Cholestech LDX¿ System combines enzymatic methodology and… — Class II medical device recall Z-1508-2022
Ongoing recall by Alere San Diego, Inc., reported 2022-08-17, distributed in AK, AL, AR, AZ, CA, CO, FL, GA…. Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because
| Recall number | Z-1508-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2022-06-24 |
| Classified | 2022-08-06 |
| Reported by FDA | 2022-08-17 |
| Distributed | AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, NC, NE, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA |
| Quantity | 436,990 |
| UPC / GTIN / UDI-DI | 00893038002616, 00893038002630, 00893038002647, 00893038002654, 00899722002344, 04571226470831 |
Product
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
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1508-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.