AU: 1800 816 696
NZ: 0800 434 246

February 2020


TGA REF: RC-2020-RN-00111-1


i-STAT CHEM8+ cartridges (blue)

i-STAT CG4+ cartridges (blue)03P85.50
i-STAT G3+ cartridges (blue)03P78.50

Dear Valued Abbott Point of Care Customer,

This letter contains important information regarding the use of capillary whole blood to run tests with the three blue i-STAT® cartridges listed above.

Please review the information contained in this Product Correction letter, as our records indicate that your facility utilizes one or more of the i-STAT cartridges associated with this communication.

If you are using the white i-STAT CG4+ cartridges (list number 03P85.25) or the white i-STAT G3+ cartridge (list number 03P78.25), this notification does not apply to those cartridges.

Abbott Point of Care is communicating this information to all potentially impacted customers in Australia. Note that this action is being conducted in cooperation with the Australian Therapeutic Goods Administration (TGA).


The three i-STAT cartridges listed above may currently be used for the quantitative measurement of sodium, potassium, chloride, urea, ionized calcium, TCO2, glucose, creatinine, lactate, pH, pCO2, pO2 and haematocrit in venous, arterial or capillary whole blood.

It has been determined that Abbott Point of Care will no longer support the use of capillary whole blood samples with the i-STAT blue CHEM8+, blue CG4+ cartridges, and blue G3+ cartridges listed in the table above. Therefore, Abbott Point of Care has decided to remove capillary whole blood as an acceptable sample type from Australian product labeling for the three cartridges listed in the table above.

This action is not being done to reduce risk to health. Abbott Point of Care has not received any reports of patient harm associated with the use of the three cartridges listed above. This correction is a safety measure to ensure that the use of capillary samples for use with the device has been appropriately clinically validated. There is no evidence to suggest that the previous use of capillary blood was inappropriate.

If you are running exclusively venous and/or arterial samples on the above i-STAT cartridges, your facility is not impacted; however, the use of capillary samples with the above i-STAT blue cartridges will no longer be an acceptable sample type.


If capillary whole blood is a required sample type at your facility for the cartridges listed above, it is recommended that your facility evaluates the potential to transition testing to an alternate i-STAT cartridge or an alternate test method that supports the use of capillary whole blood. Abbott will notify customers when the products are available for use with capillary whole blood again.

The listed cartridges may continue to be used with venous and/or arterial whole blood samples.

Please note, the white i-STAT CG4+ cartridges (list number 03P85.25) and the white i-STAT G3+ cartridge (list number 03P78.25) are not affected by this Product Correction Notification, and capillary samples will continue to be an acceptable sample type when used with these white cartridges.

If you have forwarded any of the blue i-STAT cartridges listed in the table to another facility, we request that you please provide a copy of this letter to them.


Product labeling for the three blue cartridges listed in the table will be updated to reflect the removal of the capillary claim. The updated labeling will be posted on the Abbott Point of Care International website (

If you have any questions regarding this information, please contact your Abbott Point of Care Technical Support at 1800 816 696 or or contact your Abbott Point of Care support services representative.

Abbott Point of Care sincerely apologizes for any inconvenience this may create for your facility. We appreciate your understanding in this matter and are fully committed to supporting you moving forward.

Yours sincerely,

Zaheer Khan
Quality Manager Australia and New Zealand

©2023 Abbott. All rights reserved. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

This website is governed by applicable U.S. laws and governmental regulations. The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage.

Your use of this website and the information contained herein is subject to our Website Terms and Conditions and Privacy Policy. Photos displayed are for illustrative purposes only. Any person depicted in such photographs is a model. GDPR Statement | Declaration for California Compliance Law.

Not all products are available in all regions. Check with your local representative for availability in specific markets. For in vitro diagnostic use only. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area.

Abbott - A Leader in Rapid Point-of-Care Diagnostics.