Z-1864-2011

Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used to verify the accuracy...

Name: Z-1864-2011 Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used to verify the accuracy...
Creator: Abbott Point Of Care Inc.
Published: 2010-12-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-12-17 / Terminated / root cause: design

FDA source

Abbott Point Of Care Inc. began a recall of Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used to verify the accuracy of results over the measurement range of the... on 2010-12-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1864-2011
Status: Terminated
Initiated: 2010-12-17
Posted: 2011-04-01
Terminated: 2012-10-16
Recalling firm: Abbott Medical
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.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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.
Root cause tag: design
FDA 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 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
Product codes and lots: Cardiac Marker Control Calibration Verification Set - Lot number M10208

Product code JJX

K031873Class II-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control SetI-Stat Corporation / cleared 2003-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)