Roche Diagnostics Corp. Roche brand Cardiac Reader. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche brand Cardiac Reader.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Roche Diagnostics Corp. is recalling Roche brand Cardiac Reader. due to Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026