FDAFDA · Food and drugs·Recall number Z-2121-2017
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.
Published May 31, 2017 · Recall initiated: May 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtest Holdings, Inc.
- Distributor
- Nationwide
- Lot
- Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.