(b)(4).A product recall letter was issued to all cell-dyn emerald customers who have received cell-dyn emerald cleaner (lots 6853, 6901, 6953, 6991, 7024, 7027, 7044, 7082, 7110 and/or 7119).The letter informs the customer of the issue regarding the potential for out of range controls.The letter instructs the customer to discontinue use of the suspected lot and destroy any remaining inventory.The customer is instructed that if they do not have replacement material available, they can continue to use the lot until they receive replacement material as long as their controls are in range.The customer is instructed to perform the decontamination procedure per the operators manual.The cause for the qc material out-of-range low issue has been traced to the manufacturing process for raw material used in the cell-dyn emerald cleaner.
|