Recalls

This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.

There have been reports of dual positive (Flu A + Flu B positive) results being encountered.

There have been reports of dual positive (Flu A + Flu B positive) results being encountered.

There have been reports of dual positive (Flu A + Flu B positive) results being encountered.