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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
Recalled July 5, 2017 · FDA recall Z-2650-2017 · Medtest Holdings
Hazard
Linear performance information in product insert does not match that listed in the approved premarket notification · FDA Class III
Units
319.922 L
Sold at
Nationwide Distribution
Description
Linear performance information in product insert does not match that listed in the approved premarket notification
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.
Manufacturer(s)
Medtest Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →