FDA Device recall Z-2725-2017
Medica ISE Module Calibrant A
- FDA Device
- Class III
- ongoing
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class III recall of Medica ISE Module Calibrant A by Ams Diagnostics, citing lot was not functioning properly and not exhibiting the correct physical properties.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2725-2017 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2016-02-29 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ams Diagnostics |
| Distribution | US |
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.
Reason
Lot was not functioning properly and not exhibiting the correct physical properties.
Identifiers
| code_info | P/N 5409; Lot No. 15251; Exp. Date 09/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2725-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.