Recall Z-2121-2017— Medtest Holdings, Inc.
Class III · Terminated
Class III FDA medical device recall by Medtest Holdings, Inc., initiated 2014-05-15, terminated 2017-06-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.. Reason: The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range..
- Recalling firm
- Medtest Holdings, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-05-15
- Terminated
- 2017-06-02
- Firm location
- Canton, MI, United States
Product description
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
Reason for recall
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
Data sourced from openFDA. This site is unofficial and independent of the FDA.