Date Initiated by Firm | October 16, 2002 |
Date Posted | March 13, 2003 |
Recall Status1 |
Terminated 3 on August 21, 2003 |
Recall Number | Z-0648-03 |
Recall Event ID |
25028 |
510(K)Number | K010953 K961439 K971152 K981342 |
Product Classification |
Counter, Differential Cell - Product Code GKZ
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Product | Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT
Model/List Number 01H73-01 |
Code Information |
Product Control/Lot # 9274912, (Exp. Date: 8/31/2003) Product Control/Lot # 9275012, (Exp. Date: 8/31/2003) Product Control/Lot # 9275212, (Exp. Date: 8/31/2003) |
Recalling Firm/ Manufacturer |
Abbott Laboratories 5440 Patrick Henry Drive Santa Clara CA 95054
|
For Additional Information Contact | Amy Sams 408-567-3457 |
Manufacturer Reason for Recall | Product elicits fluorescent signal interference due to contamination. |
FDA Determined Cause 2 | Other |
Action | On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
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Quantity in Commerce | 1383 units |
Distribution | Nationwide and Argentina, Canada and Puerto Rico. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GKZ 510(K)s with Product Code = GKZ
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