|ABBOTT POINT OF CARE, INC.||400 COLLEGE ROAD EAST
Princeton, NJ 08540
|T: +1 609 454 9000
f: +1 609 419 9370
United States Fall 2020 Software Release & List Number Change
Dear Valued Abbott Point of Care Customer,
As a follow up to our April 2020 letter about the U.S. FDA 510(k) clearance of the i-STAT CG4+ (blue) cartridge that explained the new reportable ranges for the i-STAT CG4+ (blue) cartridge (see below), we would like to share and reiterate some information in preparation for the i-STAT System Fall 2020 software (JAMS/CLEW) update scheduled to be released on October 5, 2020.
LIST NUMBER CHANGE
The list number for the i-STAT CG4+ (blue) cartridge will be updated from 03P85-50 to 03P85-51.
Why are we making this change? To facilitate the association of updated labeling with the i-STAT CG4+ ( blue) cartridge, the cartridge list number is being updated to 03P85-51. As a reminder, you can find the updated information in the i-STAT CG4 + (blue) cartridge "Instructions for Use" (IFU) on the Abbott Point of Care website (www.pointofcare.abbott).
As of October 5, 2020, the only list number available to order for the i-STAT CG4+ ( blue) cartridges will be 03P85-51. If you still have 03P85-50 cartridges in your inventory, you may continue to use until expiration, with a customized reportable range. For guidance on customizing your reportable range, please refer to the i-STAT Technical Bulletin - Reportable Range Customization on the i-STAT 1 Handheld (ART 730009-00C). In addition, please ensure that your facility ordering system(s) reflect the change to 03P85-51.
|i-STAT CG4+ ( blue ) Cartridges|
|List number available prior to the October 5th Fall Software release||List number available as of the October 5th Fall Software Release|
REPORTABLE RANGE CHANGE
The i-STAT System Fall 2020 Software update, will enable functionality to run the i-STAT CG4+ (blue) cartridge, 03P85-51, and the software will align the displayed results within the updated reportable range. Additionally, the i-STAT System Fall 2020 Software update will not affect the old blood gas reportable ranges for the i-STAT CG4+ ( blue) cartridge, 03P85-50. If you still have 03P85-50 cartridges in your inventory, you may continue to use to expiry with a customized reportable range. Please keep this change in mind as you plan your on-hand supply until software release.
Important: Updating your i-STAT System Fall 2020 software as soon as it is released on October 5, 2020, is required in order to use the i-STAT CG4+ (blue) cartridge, 03P85-51. As mentioned, on October 5, 2020 the only list number available to order for the i-STAT CG4+ (blue) cartridge will be 03P85-51.
As previously communicated, as a result of the U.S. FDA 510(k) clearance in April, there were updates to the reportable reference ranges for i-STAT CG4 + (blue) cartridge including pH, PCO2, and PO2 tests. See below for the new reportable ranges. The reference ranges are unchanged.
|assay||old reportable range||updated* reportable range|
|pH (pH units)||6.500 to 8.200||7.000 to 7.700|
|PCO2 (mmHg)||5.0 to 130.0||15.0 to 130.0|
|PO2 (mmHg)||5 to 800||15 to 530|
|LACTATE (mmol/L)||0.30 to 20.00||NO CHANGE|
If using i-STAT/DE or CDS for customization, ensure that the analyzers are customized with the blood gas reportable ranges aligned to the i-STAT cartridge IFU(s). When an analyzer has been customized with a range that does not fall within the reportable range in the i-STAT CG4+ ( blue) cartridge IFU, a display message will appear, and cartridge testing will not be performed.
i-STAT LIQUID QUALITY CONTROL CHANGES
To further facilitate the update to the pH reportable range for the i-STAT CG4+ ( blue) cartridge, Abbott Point of Care is adapting the i-STAT Control Level 3 to align with these new ranges. More information will be available later this year. If you are using i-STAT TriControls, there will be no changes and they may continue to be used with the CG4+ (blue) cartridges 03P85-50 and 03P85-51.
If you have forwarded any i-STAT CG4+ (blue) cartridges to another facility, we request that you please provide a copy of this letter to them.
For questions, please contact your Abbott Point of Care Sales Specialist, or Abbott Point of Care Technical Support (1-844-256-9532 or via email at email@example.com).
We understand the recent i-STAT CG4+ (blue) cartridge field action created challenges for you and sincerely apologize. We are fully committed to partnering with you to achieve our shared mission of improving the quality and efficiency of care for the patients we serve.
Abbott Point of Care
08-2020-73 U.S. Hospital Customer Letter: i-STAT CG4+ United States Fall 2020 Software Release & List Number Change
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