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.
This recall has been terminated (originally issued March 10, 2011).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- September 25, 2006
- Posted
- March 10, 2011
- Terminated
- February 27, 2012
- Recall Number
- Z-1621-2011
- Quantity
- 12,675 in US, 125 ROW
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Certain lots of G3+ cartridges may be difficult to fill.
Distribution
Worldwide distribution: USA and country of : Canada.
Lot / Code Info
Catalog number: 06F03-1, 06F03-02; Lot numbers: J06072, Exp 10/28/2006; J06076, Exp 11/14/2006; J06081, Exp 11/14/2006; J06083, Exp 11/14/2006; J06085, Exp 11/14/2006.
Root Cause
Other
Action Taken
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.