Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents a...
FDA Recall #Z-2650-2017 — Class III — October 19, 2011
Product Description
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.
Reason for Recall
Linear performance information in product insert does not match that listed in the approved premarket notification
Recalling Firm
Medtest Holdings, Inc. — Canton, MI
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
319.922 L
Distribution
Nationwide Distribution
Code Information
Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated