Recall Z-0834-2013
Ventana Medical Systems Inc · initiated September 28, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 in situ hybridization reagents.
Codes / lots: 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).
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
FDA-determined cause: Device Design
Action taken
The firm, Roche sent a "Technical Bulletin" and an letter dated October 3, 2012 to its customers. The letter and bulletin described the product, problem and actions to be taken. The customers were informed that Ventana is aggressively working on solutions to this issue. Until mitigations to the overflow condition are available for implementation; inform all personnel in your organization that work with the BenchMark ULTRA or DISCOVERY ULTRA instrument about the potential for fluid overflow to occur during decontamination cycles; follow the instructions provided in the letter to avoid the documented failure mode and follow the instructions provided in the technical bulletin. Contact your local support center with any questions or concerns or call 520-877-7191.
Details
- Recall number
- Z-0834-2013
- Initiated
- September 28, 2012
- Posted by FDA
- August 6, 2013
- Terminated
- February 24, 2016
- Product code
- KPA – Slide Stainer, Automated
- Quantity
- 54 instruments
- Distribution
- Worldwide distribution: USA (nationwide) and country of: Germany.
- Recalling firm
- Ventana Medical Systems Inc, Oro Valley, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0833-2013 Class II | VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only…Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the… | 09/28/2012Terminated |