FDA Device recall Z-0747-2013
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter r…
- FDA Device
- Class III
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class III recall of Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter r… by Alere San Diego, citing out of range (increased) HDL Cholesterol results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0747-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-10-22 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
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
Out of range (increased) HDL Cholesterol results.
Identifiers
| code_info | Lot#271097, 298148, and 301886 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0747-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.