The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-1...
FDA Recall #Z-2649-2017 — Class III — November 22, 2010
Product Description
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Reason for Recall
Incorrect control range in product labeling
Recalling Firm
Medtest Holdings, Inc. — Canton, MI
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
5 kits
Distribution
FL, AR, NICARAGUA, KOREA
Code Information
Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated