Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
FDA device recall Z-0172-06 · posted 2005-11-18 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- Reports of false negative results on Sysmex Coagulation System.
- Action taken
- On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method.
- Root cause
- Other
- Status
- Terminated
- Product code
- DAP
- Quantity affected
- 2987 units
- Distribution
- The product was shipped to medical facilities nationwide.
- Date initiated
- 2005-07-29
- Date posted
- 2005-11-18
- Date terminated
- 2006-03-01
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCED D-DIMER ASSAY (K041438) | Dade Behring, Inc. | 2004-08-11 |