Princeton Biomeditech Corp.
4242 U.S. Hwy. 1, Monmouth Jct, NJ, US
Registered product codes
43 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
4 on file
- Open, ClassifiedOct 30, 2024
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.
View FDA record ↗ - TerminatedAug 31, 2012
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
View FDA record ↗ - TerminatedAug 31, 2012
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
View FDA record ↗ - TerminatedAug 31, 2012
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
View FDA record ↗
Compliance history
Matched by FEI 2246703.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.