Medica ISE Module Calibrant A — Class III medical device recall Z-2725-2017
Ongoing recall by AMS Diagnostics, LLC, reported 2017-07-19, distributed nationwide. Lot was not functioning properly and not exhibiting the correct physical properties.
| Recall number | Z-2725-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMS Diagnostics, LLC, Weston, FL, United States |
| Recall initiated | 2016-02-29 |
| Classified | 2017-07-13 |
| Reported by FDA | 2017-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 9 units |
| Lot numbers | 15251 |
| Expiration dates | 2016-09 |
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 for recall
Lot was not functioning properly and not exhibiting the correct physical properties.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2725-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.