Overview of recall records associated with Enterix, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up…
This page summarizes recall records in which the official source identifies Enterix, Inc. 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.
