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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT cTnI cartridges

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 Class 2 Device Recall iSTAT cTnI cartridgessee related information
Date Initiated by FirmMarch 07, 2012
Date PostedAugust 22, 2012
Recall Status1 Terminated 3 on February 19, 2013
Recall NumberZ-2237-2012
Recall Event ID 62410
510(K)NumberK031739 
Product Classification Immunoassay method, troponin subunit - Product Code MMI
Producti-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Code Information 510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25  All lots
FEI Number 2245578
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information ContactMr. Larry Krasley
609-454-9272
Manufacturer Reason
for Recall		Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.
FDA Determined
Cause 2		Device Design
ActionAbbott Point of Care (APOC) sent an Urgent Recall Notice letters, via Fed Ex on March 07, 2012 to all affected customers. APOC sent an important product information update on July 19, 2012 to all of their affected customers. The letter identified the affected product, problem and actions to be taken. Customers are asked to review the information included as it may pertain to their cartridges. Customers were instructed that if the affected product have been forwarded to another facility, provide a copy of this letter to them. For additional information, contact APOC at 800-366-8020 option 1 or your Abbott Point of Care representative.
Quantity in Commerce7,057675 cartridges US; 772,400 cartridges OUS
DistributionWorldwide Distribution - US Nationwide, International
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MMI
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