Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0389-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2018-08-10 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0389-2019
Date of alert: 2018-08-10
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Medtest Holdings, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00811727011411

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0389-2019 — 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.

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