FDA Device

Roche brand Cardiac Reader.

Hazard

Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.

What You Should Do

Remedy

User hospitals were notified via phone, letter and fax (beginning on 12/3/04) a copy of the recall notification on December 3, 2004, which instructed them to immediately cease using the device. The firm issued a press release on December 8, 2004.

Products

Roche brand Cardiac Reader.
Brand
Roche Diagnostics Corp.
UPC
All units.

Units Affected

95