| Date Initiated by Firm | July 29, 2005 |
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| Date Posted | November 18, 2005 |
|---|
| Recall Status1 |
Terminated 3 on March 01, 2006 |
| Recall Number | Z-0172-06 |
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| Recall Event ID |
32887 |
| 510(K)Number | K041438 |
|---|
| Product Classification |
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - Product Code DAP
|
| Product | Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method. |
|---|
| Code Information |
Catalog number OQWM |
Recalling Firm/
Manufacturer |
Dade Behring , Inc.
500 GBC Dr., Mailstop 514
PO BOX 6101
Newark DE 19714-6101
|
| For Additional Information Contact | Aydee Crawford
302-631-6312 |
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Manufacturer Reason
for Recall | Reports of false negative results on Sysmex Coagulation System. |
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FDA Determined
Cause 2 | Other |
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| Action | 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. |
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| Quantity in Commerce | 2987 units |
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| Distribution | The product was shipped to medical facilities nationwide. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = DAP
|
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