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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT G3 Cartridge

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  Class 2 Device Recall iSTAT G3 Cartridge see related information
Date Initiated by Firm September 25, 2006
Date Posted March 10, 2011
Recall Status1 Terminated 3 on February 27, 2012
Recall Number Z-1621-2011
Recall Event ID 56637
510(K)Number K940918  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Peter J. Scott
609-454-9270
Manufacturer Reason
for Recall		 Certain lots of G3+ cartridges may be difficult to fill.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 12,675 in US, 125 ROW
Distribution Worldwide distribution: USA and country of : Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = I-STAT CORP.
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