FDA Recall
Terminated
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.
Recall: Z-0389-2019
·
Initiated August 10, 2018
Recall
- Recall Number
- Z-0389-2019
- Event Number
- 81160
- Firm
- Medtest Holdings, Inc.
- FEI Number
- 1827821
- Product Code
- LBR
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- August 10, 2018
- Terminated
- December 4, 2019
- Address
- 5449 Research Dr, Canton, MI, 48188-2261
Description
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
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Action
Notification letters dated 8/14/18 were sent to customers. Customers were also contacted via telephone on 8/10/18. Additional letters containing labels dated 8/17/18 were sent to customers.
Distribution
US Nationwide in the states of CA, FL, GA, MI, and OH.
Quantity
22