Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Roche brand Cardiac Reader.

FDA Recall Z-0383-05 · Posted 2005-01-06

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Date Initiated2004-12-03
Date Terminated2005-09-08
Product Quantity95

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000784THE CARDIAC READER SYSTEMRoche Diagnostics Corp. · 2000-05-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑