FDA Device

Roche/Hitachi Tina-quant RF II; catalog # 3004902

Hazard

Test results may exhibit a positive bias when plasma samples are used for the assay.

What You Should Do

Remedy

A reagent bulletin dated 9/30/02 was sent to all users. Customers were instructed to discontinue the use of plasma samples with this reagent.

Products

Roche/Hitachi Tina-quant RF II; catalog # 3004902
Brand
Roche Diagnostics Corp.
UPC
All lots

Units Affected

480