FDA Device

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.

Hazard

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

What You Should Do

Remedy

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.

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Products

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 plasm
Brand
Medtest Holdings, Inc.
UPC
Lot Number 808801-180; UDI: 00811727011411

Units Affected

22

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