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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Point of Care iStat cTnI cartridge

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  Class 2 Device Recall Abbott Point of Care iStat cTnI cartridge see related information
Date Initiated by Firm November 01, 2012
Date Posted January 24, 2013
Recall Status1 Terminated 3 on June 14, 2013
Recall Number Z-0716-2013
Recall Event ID 64043
510(K)Number K031739  
Product Classification Immunoassay method, troponin subunit - Product Code MMI
Product Abbott Point of Care i-Stat cTnI cartridge.

The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
Code Information List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179
Recalling Firm/
Manufacturer		 Abbott Point of Care Canada Limited
185 Corkstown Road
Nepean Canada
For Additional Information Contact Mr. Joseph Kiciena
609-454-9494
Manufacturer Reason
for Recall		 APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
FDA Determined
Cause 2		 Error in labeling
Action APOC sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Abbott Point Of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point Of Care representative for questions regarding this information.
Quantity in Commerce 560 boxes (25 cartridges in each box)
Distribution Worldwide Distribution.
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 = MMI and Original Applicant = I-STAT CORPORATION
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