Recalls / —

—#32436

Product

AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.

Affected lot / code info

Lot E12989; exp 7/04.

Why it was recalled

Marketed without PMA or 510(k) approval.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified of the removal by phone on 3/10/04.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

Florida and Virginia.

Timeline

Recall initiated

2004-03-10

Posted by FDA

2004-07-20

Terminated

2005-01-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #32436. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.