Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin
FDA device recall Z-0814-2010 · posted 2010-02-23 · Terminated
Recall details
- Recalling firm
- Abbott Point of Care Inc.
- Reason for recall
- Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.
- Action taken
- Abbott Point of Care issued an "Important Product Information" letter beginning August 18, 2009. Consignees were instructed on how to reconcile all affected product. For further information, contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- JBP
- Quantity affected
- 1,110,775 Cartridges
- Distribution
- Worldwide distribution.
- Date initiated
- 2009-08-18
- Date posted
- 2010-02-23
- Date terminated
- 2010-05-18
- Location
- Princeton, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT KAOLIN ACT TEST (K023582) | I-Stat Corporation | 2003-09-08 |