Z-2649-2017Class III

The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

Name: Z-2649-2017 The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Creator: Medtest Holdings, Inc.
Published: 2010-11-22
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2010-11-22 / Terminated / root cause: manufacturing process

FDA source

Medtest Holdings, Inc. began a recall of The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit on 2010-11-22. FDA classified it as Class III and gives the reason as "Incorrect control range in product labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2649-2017
Classification: Class III
Status: Terminated
Initiated: 2010-11-22
Posted: 2017-06-29
Terminated: 2017-07-24
Recalling firm: Horiba Instruments Incorporated
Product: The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Product code: JHW U.V. Method, Cpk Isoenzymes
Reason for recall: Incorrect control range in product labeling
Root cause tag: manufacturing process
FDA 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 in commerce: 5 kits
Distribution: FL, AR, NICARAGUA, KOREA
Product codes and lots: Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2649-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2649-2017	Class III	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29

Product code JHW

K942958Class IICreatine Kinase Mb Determination (UV)Biochemical Trade, Inc. / cleared 1994-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)