Reported Nov 14, 2018 · Terminated

Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of…

Medtest Holdings, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtest Holdings, Inc. · 5449 Research Dr · Canton, MI · 48188-2261

Is this the product you have?

  • Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog
  • Number H7545-CAL - Product UsageFor the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only
Lot codes and dates
  • Lot Number 808801-180
  • UDI00811727011411
Amount recalled
22

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 4, 2019 · Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.