FDA Device

Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.

Hazard

A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.

What You Should Do

Remedy

Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.

Products

Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
Brand
Roche Diagnostics Corp.
UPC
All units.

Units Affected

254