| Class 2 Device Recall CELLDYN 4000 | |
Date Initiated by Firm | May 12, 2004 |
Date Posted | March 16, 2007 |
Recall Status1 |
Terminated 3 on May 01, 2007 |
Recall Number | Z-0639-2007 |
Recall Event ID |
37450 |
510(K)Number | K961439 |
Product Classification |
Reagent - Product Code GIF
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Product | CELL-DYN 4000 Diluent/Sheath Reagent,
List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA |
Code Information |
Lot Numbers: 14454I2, 14455I2, 14456I2, 14457I2, 15611I2 |
Recalling Firm/ Manufacturer |
Abbott Laboratories 5440 Patrick Henry Dr Santa Clara CA 95054-1113
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Manufacturer Reason for Recall | Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range). |
FDA Determined Cause 2 | Other |
Action | On May 12, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed. |
Quantity in Commerce | 6,893 units |
Distribution | Class II- Worldwide Distribution-USA including the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, WA, WI, and WV and countries of Argentina, Brazil, Hong Kong, Japan, Malaysia, Singapore, Taiwan, and Thailand. |
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 = GIF
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