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Class 2 Device Recall Abbott |
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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
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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)
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Code Information |
All lots of 9402212 and ALL lower numbers. |
Recalling Firm/ Manufacturer |
Abbott Laboratories 5440 Patrick Henry Drive Santa Clara CA 95054
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Manufacturer Reason for Recall |
Product may elicit fluorescent signal interference due to bacterial contamination.
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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
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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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