Abbott Point Of Care Inc. Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25
Brand
Abbott Point Of Care Inc.
Lot Codes / Batch Numbers
K, L, M, N, W or Y Primary GTIN (01) 00054749000163)
Products Sold
Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)
Abbott Point Of Care Inc. is recalling Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, i due to Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.
Recommended Action
Per FDA guidance
Abbott Point of Care notified Customers via email beginning on 22 December 2020. Customer letters will begin shipping via FedEx on 28-December-2020 for delivery on or around 29-December-2020. Letter states reason for recall, health risk and action to take: While Abbott Point of Care continues to investigate this issue, if reporting ionized calcium is required, it is recommended that the i-STAT CG8+ and EG7+ cartridges be used only: within 3 days of removal from refrigerated storage for lot numbers between *20100 and *20339 within 7 days of removal from refrigerated storage for lot numbers *20340 and above Where *= lot letter A, K, L, M, N, W and Y If your facility is unable to manage to the recommended action outlined above, Abbott Point of Care recommends that your facility disable and not report the ionized calcium test on the i-STAT CG8+ and EG7+ cartridges and use an alternate i-STAT cartridge or method for reporting ionized calcium. Please see additional information below on how to disable the ionized calcium test for these cartridges. Please confirm receipt and understanding of this communication by responding to the business reply form included with this letter. Additional information regarding potential solutions will be provided separately by APOC. If you have forwardedany i-STAT CG8+ and EG7+ cartridges to another facility, we request that you please provide a copy of this letter to them. Your Abbott Point of Care sales and support team will be contacting you to review interim solutions for the challenges this communication may bring. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 1-844-256-9531, or via email at apoc_productinformation@abbott.com or visit the Abbott Point of Care website www.pointofcare.abbott. Additionally, please report any questions or concerns about the performance of the ionized calcium test on the i-STAT CG8+ and EG7+ cartridges to Abbott Point of Care Tec
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026