FDA recall Z-0389-2019

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.

Reason for recall

Vials of the autoHDL/LDL Calibrator were shipped without a vial label.

Distribution

US Nationwide in the states of CA, FL, GA, MI, and OH.

Key facts

Status

Terminated

Initiation date

2018-08-10

Report date

2018-11-14

Termination date

2019-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canton, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0389-2019