Z-1030-03

Roche/Hitachi Tina-quant RF II; catalog # 3004902

Name: Z-1030-03 Roche/Hitachi Tina-quant RF II; catalog # 3004902
Creator: Roche Diagnostics Corp.
Published: 2002-09-30
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2002-09-30 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi Tina-quant RF II; catalog # 3004902 on 2002-09-30. The reason FDA records is "Test results may exhibit a positive bias when plasma samples are used for the assay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1030-03
Status: Terminated
Initiated: 2002-09-30
Posted: 2003-07-19
Terminated: 2003-07-18
Recalling firm: Roche Diagnostics GmbH
Product: Roche/Hitachi Tina-quant RF II; catalog # 3004902
Reason for recall: Test results may exhibit a positive bias when plasma samples are used for the assay.
FDA root cause: Other
Action: A reagent bulletin dated 9/30/02 was sent to all users. Customers were instructed to discontinue the use of plasma samples with this reagent.
Quantity in commerce: 480
Distribution: United States
Product codes and lots: All lots

K002609Class IITina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp. / cleared 2000-09-05

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)