Loading...
Loading...
Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives.
Routine testing indicates product does not meet the expiration date in all cases.
The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.