Every recall we track for Abbott Point Of Care Inc. — 15 in all — plus the complaints and injury reports the public filed about them.
Abbott recalls i-STAT EG6+ cartridges with specific list numbers that may show falsely high CO2 and low pH, risking unnecessary medical interventions. Affected units may need replacement to avoid potential harm.
Abbott recalls i-STAT EG7+ and EG6+ cartridges with specific lot numbers that may show falsely high CO2 and low pH, risking unnecessary medical interventions. Affected users should check their cartridge lot numbers.
Abbott recalls i-STAT G3+ cartridges with list number 03P78-26 that may show falsely high CO2 and low pH, risking unnecessary medical interventions. Affected units may need replacement.
Abbott recalls i-STAT EG7+ cartridges due to lack of 510(k) premarket clearance for updated sample types and measurement ranges. No action needed as the product is safe for use.
Abbott recalls i-STAT CG8+ cartridges due to lack of updated 510(k) clearance for potassium and calcium measurements. Affected units may not provide accurate test results. Contact Abbott for details.
Abbott recalls i-STAT CG4+ white cartridges due to missing 510(k) premarket clearance for updated lactate and pH/PO2 measurements. No immediate action needed.
Abbott recalls i-STAT EG6+ cartridges due to lack of 510(k) premarket clearance for updated potassium and calcium measurements. No immediate action needed as this is a regulatory issue, not a safety hazard.
Abbott recalls i-STAT EG7+ cartridges that may show higher than expected calcium results when stored at room temperature for more than 3 days (lots *20100-*20339) or 7 days (lots *20340+).
Abbott recalls i-STAT CG8+ cartridges that may show higher than expected calcium results when stored at room temperature for more than 3 days (lots *20100-*20339) or 7 days (lots *20340+).
Abbott recalls blue i-STAT CHEM8+ cartridges (List No. 09P31-25) as they are not FDA cleared and lack CLIA waived status, risking improper lab testing.
Abbott recalls i-STAT CG4+ blue cartridges (List No. 03P85-50) as they are not FDA cleared and lack CLIA waived status, risking improper lab testing.
Abbott recalls blue i-STAT G3+ cartridges due to insufficient clinical evidence for safety and performance. All units are affected; stop using immediately to avoid potential risks.
Abbott recalls i-STAT cTnI blue cartridges that may generate 3-5% quality check errors. Affected units sold with specific list numbers. Consumers should check their cartridges for the listed identifiers.
Abbott recalls i-STAT CG8+ potassium cartridges that may give inaccurate potassium results, especially with low or high potassium samples. Affected units include specific lot numbers and box numbers.
