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Recall Observatory FDA recall evidence

Device 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.

Z-2725-2017

February 29, 2016

Class III

Product summary

Firm
AMS Diagnostics, LLC
Event
Event 77481
Status
Ongoing
Classification
Class III
Quantity
9 units
Official record key
device-enforcement:Z-2725-2017

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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