i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.
FDA Recall Z-1621-2011 · Posted 2011-03-10
Advertisement
Recalling FirmAbbott Point Of Care Inc.
Recall StatusTerminated
Product CodeCHL
Date Initiated2006-09-25
Date Terminated2012-02-27
Product Quantity12,675 in US, 125 ROW
Reason for Recall
Certain lots of G3+ cartridges may be difficult to fill.
Firm Action
The firm, Abbott Point of Care, sent a "Important notice" letter dated September 25, 2006 to all customers. The letter described the product, problem and actions to be taken. The customers were to destroy and discard the i-STAT G3+ Cartridges and complete and return the customer reply form. Abbott sent replacements cartridges to their customers.
If you or any of the healthcare providers you serve have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1.
Root Cause
Other
Distribution Pattern
Worldwide distribution: USA and country of : Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement