I-STAT EG7+ Cartridge Abbott Point of Care — Class II medical device recall Z-2133-2012
Terminated recall by Abbott Point Of Care Inc., reported 2012-08-08, distributed nationwide. i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at ro
| Recall number | Z-2133-2012 |
|---|---|
| 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 | 2011-01-01 |
| Classified | 2012-08-02 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 52,750 cartridges |
| Lot numbers | S10246A |
Product
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
Reason for recall
i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
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-2133-2012. 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.