—#43773

Product

CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K010953
Affected lot / code info: List Number: 07H22-01, lot numbers: 16328 and 29401

Why it was recalled

T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.

Root cause (FDA determination)

Other

Action the firm took

The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.

Timeline

Recall initiated: 2005-12-16
Posted by FDA: 2006-02-16
Terminated: 2006-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43773. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.