Pointe Scientific AutoHDL/LDL Cholesterol Calibrator — Class III medical device recall Z-0389-2019
Terminated recall by Medtest Holdings, Inc., reported 2018-11-14, distributed nationwide. Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
| Recall number | Z-0389-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtest Holdings, Inc., Canton, MI, United States |
| Recall initiated | 2018-08-10 |
| Classified | 2018-11-05 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2019-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 22 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00811727011411 |
| Lot numbers | 808801-180 |
| Model numbers | H7545-CAL |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0389-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.