February 2020

PRODUCT DEFECT CORRECTION

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

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).

BACKGROUND

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.

RECOMMENDED ACTIONS

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.

ADDITIONAL INFORMATION

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 (https://www.pointofcare.abbott/int/).

If you have any questions regarding this information, please contact your Abbott Point of Care Technical Support at 1800 816 696 or AU_ADD_CSH@abbott.com 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