Alere Cholestech LDX Calibration Verification — Class III medical device recall Z-0747-2013
Terminated recall by Alere San Diego, Inc., reported 2013-02-06, distributed nationwide. Out of range (increased) HDL Cholesterol results.
| Recall number | Z-0747-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2012-10-22 |
| Classified | 2013-01-29 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2013-09-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR |
| Quantity | 614 kits |
| Lot numbers | 271097, 298148, 301886 |
| Model numbers | 88770 |
Product
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.
Reason for recall
Out of range (increased) HDL Cholesterol results.
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-0747-2013. 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.