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Recall Observatory FDA recall evidence

Device 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.

Z-2121-2017

May 15, 2014

Class III

Product summary

Firm
Medtest Holdings, Inc.
Event
Event 77083
Status
Terminated
Classification
Class III
Quantity
132919 Vol vials
Official record key
device-enforcement:Z-2121-2017

Official wording

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.

Code information: Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.