Recall Z-2650-2017
Medtest Holdings, Inc. · initiated October 19, 2011
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.
Reason for recall
Linear performance information in product insert does not match that listed in the approved premarket notification
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-2650-2017
- Initiated
- October 19, 2011
- Posted by FDA
- June 29, 2017
- Terminated
- July 24, 2017
- Product code
- CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Quantity
- 319.922 L
- Distribution
- Nationwide Distribution
- Recalling firm
- Medtest Holdings, Inc., Canton, MI