FDA recall Z-0590-2021

Product

InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.

Reason for recall

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 diagnostic procedure, i.e., colonoscopy or sigmoidoscopy

Distribution

Worldwide distribution - US Nationwide and the country of Australia.

Key facts

Status

Terminated

Initiation date

2020-10-08

Report date

2020-12-23

Termination date

2023-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Edison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0590-2021