Overview of recall records associated with PROTERIXBIO, including dates, categories and classifications where available.
Classification mix: Class II: 1.
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
This page summarizes recall records in which the official source identifies PROTERIXBIO as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
