Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism o
FDA device recall Z-1341-2011 · posted 2011-02-16 · Terminated
Recall details
- Recalling firm
- Abbott Point Of Care Inc.
- Reason for recall
- Celite ACT cartridges have increased numbers of values outside the accepted allowable error.
- Action taken
- On behalf of Abbott, Genco Pharmaceutical Services sent an "URGENT RECALL NOTICE" dated November 2010, on December 3, 2010 via Fedex to all consignees/customers. Abbott sent out notification packages to foreign consignees/customers on December 3, 2010. The notice described the product, problem and action to be taken by customers. The firm recommended that customers use cartridges within 12 hours of removal from refrigerated storage based on the instructions provided with the product. The customers were instructed to complete and return the Business Reply cards to acknowledge receipt of the communication and provide the letter to any customers that have recieved the product. If you have any additional questions, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care Representative. On February 27, 2012 Abbott sent an Important Product Information letter via Fed Ex to inform customers that i-Stat Celite ACT cartridges manufactured from the beginning of 2012 can now be stored for two weeks at room temperature as indicated on the cartridge box. Foreign consignees were notified on 2/28/2012. Users are instructed to complete business reply cards to acknowledge receipt of the communication and provide the letter to any customers that have received the product. Any additional questions can be answered by contacting 8003668020 option 1.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JBP
- Quantity affected
- 1164275 cartridges
- Distribution
- Worldwide distribution.
- Date initiated
- 2010-12-03
- Date posted
- 2011-02-16
- Date terminated
- 2013-07-16
- Location
- Princeton, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT SYSTEM (K992571) | I-Stat Corp. | 2000-02-10 |