| Class 2 Device Recall CELLDYN | |
Date Initiated by Firm | February 24, 2004 |
Date Posted | March 17, 2007 |
Recall Status1 |
Terminated 3 on May 01, 2007 |
Recall Number | Z-0640-2007 |
Recall Event ID |
37444 |
510(K)Number | K961439 |
Product Classification |
Diluent/Sheath 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: 10916I2, 10917I2, 10918I2, 10919I2, 10920I2, 10921I2 |
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-product 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 | Recall Letter-On 2/24/04, the firm initiated the recall and its notification explaining the reason for the recall and requesting the product be destroyed |
Quantity in Commerce | 9,800 units |
Distribution | Worldwide Distribution-USA including states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, lA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV. and countries of Australia, Argentina, Brazil, Hong Kong, Japan, Korea, Malaysia, Singapore. |
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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