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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott

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  Class 2 Device Recall Abbott see related information
Date Initiated by Firm January 10, 2003
Date Posted March 12, 2003
Recall Status1 Terminated 3 on September 17, 2003
Recall Number Z-0632-03
Recall Event ID 25503
Product Classification Mixture, Hematology Quality Control - Product Code JPK
Product Abbott brand DILUENT/SHEATH, CELL-DYN¿ 4000 System
CELL-DYN REAGENT PART A
Model/List Number 01H77-01 (4x3.8L), 01H75-01A (3.8L)
Code Information All lots of 9402212 and ALL lower numbers.
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Drive
Santa Clara CA 95054
Manufacturer Reason
for Recall		 Product may elicit fluorescent signal interference due to bacterial contamination.
FDA Determined
Cause 2		 Other
Action On 1/31/03, the firm initiated the recall and their notification was via letters requesting 'locate and discard' affected device.
Quantity in Commerce 8826 units
Distribution Product was released for distribution to 428 consignees in U.S. and 17 foreign consignees. The U.S. States include: AL, AZ, CA, CO, FL, GA, IA, MN, MO, NY, NC, SC, TN, TX and UT; and foreign accounts include: Argentina, Canada and Puerto Rico. Product was distributed to 10 U.S. Government accounts: (1) AK Native Med Center Supply 4315 Diplomacy Dr. Anchorage, AK 99508 907-729-1200 (2) Walter Reed Army Medical 6900 georgia Ave. NW Washington DC 20307 202-782-2579 (3) WHMC Medical material Mgr. 2200 Bergquest Dr. lackland AFB, TX 78236 (210)-670-7505 (4) DD Eisenhower AMC PAT E. Hospital Rd. Fort Gorden, GA 80220 (706) 791-2430 (5) VA Medical Center 1055 Claremont St. Denver, CO 80220 (303) 399-8020 (6) VA Hospital Supply 500 Foothill Dr. Salt Lake City, UT 84148 (801) 584-1248 (7) WHMC Medical Material Mgr. 2200 Bergquist Dr. Lackland AFB, TX 78236 (210) 670-7505 (8) VA Medical Center 650 E. Indian School Rd. Phoenix, AZ 85012 (602) 277-5551 (9) VA Medical Center 109 Bee St. Charleston, SC 29401 (843) 577-5011 (10) USPHS Phoenix 4212 N. 16th St. Phoenix, AZ 85016 (602) 263-1585
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.
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