Z-2650-2017Class III

Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer...

Name: Z-2650-2017 Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer...
Creator: Medtest Holdings, Inc.
Published: 2011-10-19
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2011-10-19 / Terminated / root cause: labeling and UDI

FDA source

Medtest Holdings, Inc. began a recall of Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the... on 2011-10-19. FDA classified it as Class III and gives the reason as "Linear performance information in product insert does not match that listed in the approved premarket notification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2650-2017
Classification: Class III
Status: Terminated
Initiated: 2011-10-19
Posted: 2017-06-29
Terminated: 2017-07-24
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Product code: CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Reason for recall: Linear performance information in product insert does not match that listed in the approved premarket notification
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Pointe Scientific/Technical Bulletin sent notifications on October 19, /2011, 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: 319.922 L
Distribution: Nationwide Distribution
Product codes and lots: Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2650-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2650-2017	Class III	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29

Product code CGS

K972155Class IICreatine Kinase (Ck)Stanbio Laboratory / cleared 1997-07-17

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)