Z-2649-2017 Class III Terminated
FDA device recall Z-2649-2017 was initiated by Medtest Holdings, Inc. on November 22, 2010 and is designated Class III. Reason for recall: Incorrect control range in product labeling The recall status is terminated (terminated July 24, 2017). Affected quantity: 5 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- November 22, 2010
- Termination Date
- July 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 kits
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
Distribution Pattern
FL, AR, NICARAGUA, KOREA
Code Information
Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03