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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT

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  Class 2 Device Recall iSTAT see related information
Date Initiated by Firm December 12, 2006
Date Posted January 23, 2007
Recall Status1 Terminated 3 on August 15, 2007
Recall Number Z-0364-2007
Recall Event ID 36991
510(K)Number K020355  
Product Classification prothrombin time test in vitro diagnostic. - Product Code GJS
Product i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic.
Ref 04J50-01
24
IVD
Abbott Point of Care Inc.
104 Windsor Center Drive
East Windsor, NJ 08520

Product of Canada
Code Information Product list #''s 04J50-01 and 04J50-02, catalog # 420200  Lot numbers: N06227, N06175A, N06176, N06179, N06181, N06186, N06188,, N06194, N06195A, N06200A, N06201A, N06201B, N06201C, N06202, N06206, N06206B, N06208, N06208A, N06209, N06222, N06222A, N06222B, N06223, N06227, N06227A, N06227B, N06235, N06235A, N06236A, N06236B, N06237, N06241, N06241A, N06241B, N06243, N06244, N06251, N06254, N06256, N06258C, N06262, N06263, N06265, N06265A, N06265B, N06265C, N06265D, N06265E, N06266, N06266A, N06267, N06268, N06268A, N06269, N06269A, N06273, N06274, N06274A, N06274B, N06274C, N06275, N06275A, N06275B, N06275C, N06276, N06277, N06277A, N06277B, N06282, N06285, N06285B, N06285C, N06290A, N06294, N06294A, N06295, N06298, N06298A, N06298B, N06301A, N06303, N06304, N06308, N06309, N06310A, N06311,
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
104 Windsor Center Dr
East Windsor NJ 08520-1407
For Additional Information Contact Paul VanDerWerf
609-443-9300
Manufacturer Reason
for Recall		 Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.
FDA Determined
Cause 2		 Other
Action Customers were notified by letter sent by regular mail on 12/13/2006.
Quantity in Commerce 14,045 boxes of 24
Distribution Nationwide to hospitals and health care facilities
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 = GJS and Original Applicant = I-STAT CORPORATION
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