FDA Device recall Z-0389-2019
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s…
- FDA Device
- Class III
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class III recall of Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s… by Medtest Holdings, citing vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0389-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-10 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtest Holdings |
| Distribution | US |
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
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Identifiers
| code_info | Lot Number 808801-180; UDI: 00811727011411 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0389-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.