i-STAT G3+ cartridge — Class II medical device recall Z-1265-2020
Terminated recall by Abbott Point Of Care Inc., reported 2020-02-26, distributed nationwide. Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evide
| Recall number | Z-1265-2020 |
|---|---|
| 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 | 2020-01-14 |
| Classified | 2020-02-18 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2021-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 4,448,525 |
| UPC / GTIN / UDI-DI | 00054749002283 |
Product
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
Reason for recall
Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020.
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-1265-2020. 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.