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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 Recall
Abbott Point of Care iStat cTnI cartridge
see related information
Date Posted January 24, 2013
Recall Status1 Terminated on June 14, 2013
Recall Number Z-0716-2013
Recall Event ID 64043
Premarket Notification
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
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MMI and Original Applicant = I-STAT CORPORATION
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