—#50559

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

FDA product code: GIF — Diluent, Blood Cell
Device class: Class 1
Medical specialty: Hematology
510(k) numbers: K961439
Affected lot / code info: Lot Numbers: 10916I2, 10917I2, 10918I2, 10919I2, 10920I2, 10921I2

Why it was recalled

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).

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2004-02-24
Posted by FDA: 2007-03-17
Terminated: 2007-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50559. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.