i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and high-level heparin therapy through an
FDA device recall Z-0399-2011 · posted 2010-11-17 · Terminated
Recall details
- Recalling firm
- Abbott Point Of Care Inc.
- Reason for recall
- Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
- Action taken
- Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material. Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material. All unused cartridges will be credited and will be returned. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- JBP
- Quantity affected
- 49,025 cartridges.
- Distribution
- Worldwide Distribution
- Date initiated
- 2010-10-06
- Date posted
- 2010-11-17
- Date terminated
- 2012-08-22
- Location
- Princeton, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT SYSTEM (K992571) | I-Stat Corp. | 2000-02-10 |