—#50573

Product

CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

FDA product code: GIF — Diluent, Blood Cell
Device class: Class 1
Medical specialty: Hematology
510(k) numbers: K972354
Affected lot / code info: Lot Numbers: 14465I2, 15597I2, 15598I2, 16752I2, 16753I2, 16754I2, 17943I2, 17946I2, 17947I2, 17949I2, 17950I2, 17952I2, 17953I2, 17954I2, 18107I2, 18108I2, 18109I2, 18110I2

Why it was recalled

Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range

Root cause (FDA determination)

Other

Action the firm took

On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republic, Germany, Hong Kong, Japan, Korea, New Zealand, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad & Tobago, Uruguay, and Venezuela.

Timeline

Recall initiated: 2004-09-29
Posted by FDA: 2007-04-03
Terminated: 2007-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.