FDA recall Z-2725-2017

Product

Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

Reason for recall

Lot was not functioning properly and not exhibiting the correct physical properties.

Distribution

US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.

Key facts

Status

Ongoing

Initiation date

2016-02-29

Report date

2017-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2725-2017