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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiac Marker Control Calibration Verification Set

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  Class 2 Device Recall Cardiac Marker Control Calibration Verification Set see related information
Date Initiated by Firm December 17, 2010
Date Posted April 01, 2011
Recall Status1 Terminated 3 on October 16, 2012
Recall Number Z-1864-2011
Recall Event ID 57742
510(K)Number K031873  
Product Classification Single (Specified) Analyte Controls (Assayed and Unassayed) - Product Code JJX
Product Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02.

Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test.
Code Information Cardiac Marker Control Calibration Verification Set - Lot number M10208
Recalling Firm/
Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Joseph Kiceina
Manufacturer Reason
for Recall
Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration Verification Set.
FDA Determined
Cause 2
Device Design
Action Urgent Recall Notice letters with business reply cards were sent Fed ex on December 17, 2010 to all accounts. International notifications were sent on December 21, 2010. The letter identified the affected product and lot numbers along with a background explanation of the issue. The firm recommends that customers remove the cap from the vial; squeeze the vial 10 times, prior to thawing; replace cap on the vial; and then follow the remaining steps for use as outlines in section 14-12 of the i-STAT 1 System Manual. Customers are to complete and return the Business Reply card to acknowledge receipt of the letter. If the affected product had been further distributed then a copy of the letter should be provided to those customers as well. If additional information is needed, customers should contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or their Abbott Point of Care representative.
Quantity in Commerce 557 units total
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 = JJX and Original Applicant = I-STAT CORPORATION