Recall Z-2649-2017— Medtest Holdings, Inc.

Name: FDA recall Z-2649-2017
Creator: U.S. Food and Drug Administration
Published: 2010-11-22

Class III · Terminated

Class III FDA medical device recall by Medtest Holdings, Inc., initiated 2010-11-22, terminated 2017-07-24. It names one FDA 510(k) clearance: K942958. Product: The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit. Reason: Incorrect control range in product labeling.

Recalling firm: Medtest Holdings, Inc.
Classification: Class III
Status: Terminated
Initiated: 2010-11-22
Terminated: 2017-07-24
Firm location: Canton, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K942958 — CREATINE KINASE MB DETERMINATION (UV)Biochemical Trade, Inc.·cleared 1994-11-21

K-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

The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

Reason for recall

Incorrect control range in product labeling

Data sourced from openFDA. This site is unofficial and independent of the FDA.