Device 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.
Z-0747-2013
Product summary
- Event
- Event 63918
- Status
- Terminated
- Classification
- Class III
- Quantity
- 614 kits
- Official record key
device-enforcement:Z-0747-2013
Official wording
Reason: Out of range (increased) HDL Cholesterol results.
Code information: Lot#271097, 298148, and 301886
Distribution pattern: Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Derived failure modes
-
Unknown
Out of range (increased) HDL Cholesterol results.