AMS Diagnostics, LLC: Medical Device Recall in 2017 - (Recall #: Z-2725-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: February 29, 2016

Date Posted: July 19, 2017

Recall Number: Z-2725-2017

Event ID: 77481

Reason for Recall:

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

Status: Ongoing

Product Quantity: 9 units

Code Information:

P/N 5409; Lot No. 15251; Exp. Date 09/2016

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated