Recall Z-1864-2011 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Abbott Point Of Care Inc.
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.
| Date | Apr 1, 2011 (initiated Dec 17, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 r |
| Quantity | 557 units total |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031873 | I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET I-Stat Corporation, Oct 7, 2003 |