Recall archive / FDA device enforcement
The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL... — FDA record Z-1508-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 24, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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).
- Classification
- Class II
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- 436,990
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1508-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All lots of Part/UDI-DI: 10-991/00893038002654, 99021/00899722002344, 14-531/04571226470831, 10-990/00893038002647, 10-989/00893038002630, 10-987/00893038002616 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 17, 2022
- Recall initiation date
- Jun 24, 2022
- Center classification date
- Aug 6, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.