Medical device recalls

Medtest Holdings, Inc. recalls The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

Recall date
November 22, 2010
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2649-2017
FDA classification
Class III
Brand / firm
Medtest Holdings, Inc.
Sold / distributed
FL, AR, NICARAGUA, KOREA

Why it was recalled

Incorrect control range in product labeling

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

What was recalled

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

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