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Terminated

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

FDA Recall Z-1030-03 · Posted 2003-07-19

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Date Initiated2002-09-30
Date Terminated2003-07-18
Product Quantity480

Reason for Recall

Test results may exhibit a positive bias when plasma samples are used for the assay.

Firm 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.

Root Cause

Other

Distribution Pattern

United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002609TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEMRoche Diagnostics Corp. · 2000-09-05

Official Source

View FDA Recall →

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

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