Medtest Holdings, Inc. recalls Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vi…

Recall date

May 15, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2121-2017

FDA classification

Class III

Brand / firm

Medtest Holdings, Inc.

Sold / distributed

Nationwide

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.