FDA recall Z-0741-2020

Product

PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

Reason for recall

This lot of test strips is showing an under-recovery when tested against a reference method.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2016-03-15

Report date

2020-01-01

Termination date

2020-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2020