—#25937

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)

FDA product code: JPK — Mixture, Hematology Quality Control
Device class: Class 2
Medical specialty: Hematology
Affected lot / code info: All lots of 9402212 and ALL lower numbers.

Why it was recalled

Product may elicit fluorescent signal interference due to bacterial contamination.

Root cause (FDA determination)

Other

Action the firm took

On 1/31/03, the firm initiated the recall and their notification was via letters requesting 'locate and discard' affected device.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Drive, Santa Clara, California 95054

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2003-01-10
Posted by FDA: 2003-03-12
Terminated: 2003-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #25937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.