FDAFDA · Food and drugs·Recall number Z-0741-2020
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Published January 1, 2020 · Recall initiated: March 15, 2016
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
This lot of test strips is showing an under-recovery when tested against a reference method.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Polymer Technology Systems, Inc.
- Distributor
- The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.
- Lot
- Lot Number I502, UDI 00381932412018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.