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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT BNP cartridge

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  Class 2 Device Recall iSTAT BNP cartridge see related information
Date Initiated by Firm January 01, 2008
Date Posted November 03, 2010
Recall Status1 Terminated 3 on September 14, 2011
Recall Number Z-0319-2011
Recall Event ID 56668
510(K)Number K053597  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product i-STAT BNP cartridge
Abbott Point of Care,
Princeton, NJ 08540
Code Information 06F30-01;06F30-02: This product has various expiration dates. All products have expired.
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Peter J. Scott
609-454-9000
Manufacturer Reason
for Recall		 i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.
FDA Determined
Cause 2		 Other
Action Abbott Point Of Care Inc.sent notification letters with a customer reply form to all affected customer in January, 2008. All distributors outside the US who were sent shipments from the affected lots were notified of the lot numbers that were affected. Affected product is to be quarantined and returned for replacement. Customers with questions about this recall can contact Abbott Point Of Care at 609 454-9000.
Quantity in Commerce 482,500 (total)
Distribution Worldwide Distribution: USA and 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 CORPORATION
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