FDA Device

Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.

Hazard

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

What You Should Do

Remedy

A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.

Products

Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.
Brand
Roche Diagnostics Corp.
UPC
All units.