Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a Recalled by Medtest Holdings, Inc. Due to Linear performance information in product insert does not...

Date: October 19, 2011
Company: Medtest Holdings, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtest Holdings, Inc. directly.

Affected Products

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.

Quantity: 319.922 L

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtest Holdings, Inc.

Medtest Holdings, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report