Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used to verify the accuracy of results
FDA device recall Z-1864-2011 · posted 2011-04-01 · Terminated
Recall details
- Recalling firm
- Abbott Point Of Care Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JJX
- Quantity affected
- 557 units total
- Distribution
- Worldwide Distribution
- Date initiated
- 2010-12-17
- Date posted
- 2011-04-01
- Date terminated
- 2012-10-16
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET (K031873) | I-Stat Corporation | 2003-10-07 |