Recalls / —

—#27748

Product

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

510(k) numbers

K002609

Affected lot / code info

All lots

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern

United States

Timeline

Recall initiated

2002-09-30

Posted by FDA

2003-07-19

Terminated

2003-07-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.