i-STAT G3+ Cartridge pH — Class II medical device recall Z-1306-2014
Terminated recall by Abbott Point Of Care Inc., reported 2014-04-02, distributed nationwide. Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartrid
| Recall number | Z-1306-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Point Of Care Inc., Princeton, NJ, United States |
| Recall initiated | 2014-01-01 |
| Classified | 2014-03-27 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2014-10-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Lot numbers | N13183 |
Product
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Reason for recall
Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.
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-1306-2014. 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.