FDA Device

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

Hazard

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%.

What You Should Do

Remedy

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.

Products

CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
Brand
Abbott Laboratories
UPC
List Number: 07H22-01, lot numbers: 16328 and 29401

Units Affected

871 units