FDA-Device2017-05-31Class III
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.
Medtest Holdings, Inc.
Hazard
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.
Sold states
Nationwide
Affected count
132919 Vol vials
Manufactured in
5449 Research Dr, Canton, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2121-2017Don't want to check this manually?
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