FDAClass IIINovember 14, 2018

Pointe Scientific AutoHDL/LDL Cholesterol Calibrator recall

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

Why was Pointe Scientific AutoHDL/LDL Cholesterol Calibrator recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 808801-180; UDI: 00811727011411

Product
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and…
Recalling firm
Medtest Holdings, Inc.
Quantity
22
Distribution
US Nationwide in the states of CA, FL, GA, MI, and OH.
Recall date
November 14, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls