Medtest Holdings, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2121-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: May 15, 2014

Date Posted: May 31, 2017

Recall Number: Z-2121-2017

Event ID: 77083

Reason for Recall:

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.

Status: Terminated

Product Quantity: 132919 Vol vials

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

Voluntary or Mandated:

Voluntary: Firm initiated