Medtest Holdings, Inc. recalls Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK…

Recall date

October 19, 2011

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2650-2017

FDA classification

Class III

Brand / firm

Medtest Holdings, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Linear performance information in product insert does not match that listed in the approved premarket notification

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.