VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or
Check against the official notice below — it lists the full affected range.
Ventana Medical Systems Inc. is recalling the DISCOVERY ULTRA Advanced Staining System (Research Use Only) due to a potential waste fluid overflow condition that can occur during decontamination cycles. The waste fluid drainage system may become restricted by debris buildup in the tubing and in-line filter, which can reduce flow rates and cause fluid overflow. Fifty-four instruments with specific serial numbers have been distributed worldwide, including throughout the USA and Germany.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of flu
Reason for recall: Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of flu Distribution: Worldwide distribution: USA (nationwide) and country of: Germany. Quantity: 54 instruments Lot/code info: Cat#750-601; PN 05987750001; Serial #'s: 310646, 311573, 310477, 311725, 311042, 311623, 312032, 312159, 310615, 310837, 311862, 311043 311572, 311766, 310526, 311011, 311185, 311723, 312082, 310635, 311574, 312084, 310636, 310835, 311179, 310493, 311183, 311769, 311930, 311962, 311963, 310437, 311965, 310997, 311726, 311620, 311512, 311526, 312083, 310468, 310759 (All serial numbers in the market).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.