Medtest Holdings, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2650-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: October 19, 2011

Date Posted: July 5, 2017

Recall Number: Z-2650-2017

Event ID: 77445

Reason for Recall:

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

Status: Terminated

Product Quantity: 319.922 L

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.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated