FDA-Device2017-07-05Class III
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Medtest Holdings, Inc.
Hazard
Incorrect control range in product labeling
Sold states
FL, AR, NICARAGUA, KOREA
Affected count
5 kits
Manufactured in
5449 Research Dr, N/A, Canton, MI, United States
Products
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2649-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief