Z-2725-2017Class III

Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use...

Name: Z-2725-2017 Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use...
Creator: AMS Diagnostics, LLC
Published: 2016-02-29
License: https://open.fda.gov/license/

Ams Diagnostics / initiated 2016-02-29 / Open, Classified / root cause: labeling and UDI

FDA source

AMS Diagnostics, LLC began a recall of 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... on 2016-02-29. FDA classified it as Class III and gives the reason as "Lot was not functioning properly and not exhibiting the correct physical properties". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2725-2017
Classification: Class III
Status: Open, Classified
Initiated: 2016-02-29
Posted: 2017-07-13
Recalling firm: Ams Diagnostics
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.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Lot was not functioning properly and not exhibiting the correct physical properties.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: AMS Diagnostics contacted consignees by telephone on 02/29/2017. Representatives advised consignees to discard any recalled product on hand, to be replaced with working product. Customers should not return recalled product to the firm.
Quantity in commerce: 9 units
Distribution: US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
Product codes and lots: P/N 5409; Lot No. 15251; Exp. Date 09/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2725-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2725-2017	Class III	Ongoing	Voluntary: Firm initiated	2017-07-19	2017-07-13

Product code JIX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)