Recalls / —

—#36108

Product

Roche brand Cardiac Reader.

510(k) numbers

K000784

Affected lot / code info

All units.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

United States.

Timeline

Recall initiated

2004-12-03

Posted by FDA

2005-01-06

Terminated

2005-09-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #36108. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.