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.
This recall is currently active, issued February 29, 2016. It was issued by Ams Diagnostics, Llc.
- Company
- Ams Diagnostics, Llc
- Recall Initiated
- February 29, 2016
- Recall Number
- Z-2725-2017
- Quantity
- 9 units
- Firm Location
- Weston, FL
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
P/N 5409; Lot No. 15251; Exp. Date 09/2016
Root Cause
Labeling mix-ups
Action Taken
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.
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