FDA Medical Device Recalls (openFDA)
Medtest Holdings, Inc.: The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
- Recall number
- Z-2649-2017
- Recalling firm
- Medtest Holdings, Inc.
- Product
- The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
- Status
- Terminated
- Initiated
- 2010-11-22
- Posted
- 2017-06-29
- Terminated
- 2017-07-24
- Reason
- Incorrect control range in product labeling
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 5 kits
- Distribution
- FL, AR, NICARAGUA, KOREA
- Lot, serial or model codes
- Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03
- 510(k) numbers
- ["K942958"]
- PMA numbers
- not on file
- Product code
- JHW
- Firm FEI
- 1827821
- Firm city
- Canton
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28