FDA-Device2020-01-01Class II
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Polymer Technology Systems, Inc.
Hazard
This lot of test strips is showing an under-recovery when tested against a reference method.
Sold states
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.
Affected count
6467
Manufactured in
7736 Zionsville Rd, Indianapolis, IN, United States
Products
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2020Don't want to check this manually?
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