Recall Z-2649-2017
Medtest Holdings, Inc. · initiated November 22, 2010
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Codes / lots: Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03
Reason for recall
Incorrect control range in product labeling
FDA-determined cause: Employee error
Action taken
On 11/22/2010, TECHNICAL BULLETIN notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.
Details
- Recall number
- Z-2649-2017
- Initiated
- November 22, 2010
- Posted by FDA
- June 29, 2017
- Terminated
- July 24, 2017
- Product code
- JHW – U.V. Method, Cpk Isoenzymes
- Quantity
- 5 kits
- Distribution
- FL, AR, NICARAGUA, KOREA
- Recalling firm
- Medtest Holdings, Inc., Canton, MI