Recall Z-2650-2017— Medtest Holdings, Inc.
Class III · Terminated
Class III FDA medical device recall by Medtest Holdings, Inc., initiated 2011-10-19, terminated 2017-07-24. It names one FDA 510(k) clearance: K972155. 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.. Reason: Linear performance information in product insert does not match that listed in the approved premarket notification.
- Recalling firm
- Medtest Holdings, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2011-10-19
- Terminated
- 2017-07-24
- Firm location
- Canton, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.