Z-0383-05

Roche brand Cardiac Reader

Name: Z-0383-05 Roche brand Cardiac Reader
Creator: Roche Diagnostics Corp.
Published: 2004-12-03
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-12-03 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche brand Cardiac Reader on 2004-12-03. The reason FDA records is "Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0383-05
Status: Terminated
Initiated: 2004-12-03
Posted: 2005-01-06
Terminated: 2005-09-08
Recalling firm: Roche Diagnostics GmbH
Product: Roche brand Cardiac Reader.
Reason for recall: Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
FDA root cause: Other
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.
Quantity in commerce: 95
Distribution: United States.
Product codes and lots: All units.

K000784Class IIThe Cardiac Reader SystemRoche Diagnostics Corp. / cleared 2000-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)