Device product
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
Z-0389-2019
Product summary
- Event
- Event 81160
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22
- Official record key
device-enforcement:Z-0389-2019
Official wording
Reason: Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Code information: Lot Number 808801-180; UDI: 00811727011411
Distribution pattern: US Nationwide in the states of CA, FL, GA, MI, and OH.
Derived failure modes
-
Unknown
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.