Recall Z-0389-2019 ยท LBR Ldl & Vldl Precipitation, Hdl
Medtest Holdings, Inc.
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.
| Date | Aug 10, 2018 |
| Status | Terminated |
| Reason | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. |
| Root cause | Error in labeling |
| 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. |
| Quantity | 22 |
| Distribution | US Nationwide in the states of CA, FL, GA, MI, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET Pointe Scientific, Inc.,, Aug 5, 1999 |