FDA Device

Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001.

Hazard

If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.

What You Should Do

Remedy

Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.

Products

Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001.
Brand
Roche Diagnostics Corp.
UPC
All units.