Recall Z-2725-2017 ยท JIX Calibrator, Multi-Analyte Mixture
AMS Diagnostics, LLC
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.
| Date | Feb 29, 2016 |
| Status | Open, Classified |
| Reason | Lot was not functioning properly and not exhibiting the correct physical properties. |
| 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 | 9 units |
| Distribution | US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.