—#50574

Product

CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 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: K051215, K961439
Affected lot / code info: All lots

Why it was recalled

High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.

Root cause (FDA determination)

Other

Action the firm took

On 4/17/06, the firm initiated the recall and its notification letters explained the reason for the recall and reported Abbott Field Service personnel will install and replace filters at all recall sites

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, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV and Countriers of Argentina, Australia, Brazil, Hong Kong, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, and Venezuela.

Timeline

Recall initiated: 2006-04-17
Posted by FDA: 2007-04-03
Terminated: 2007-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50574. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.