Recall Z-0538-2008 ยท KPA Slide Stainer, Automated
Ventana Medical Systems Inc
Benchmark XT, Slide Staining System, Catalog Number: N750-BMKXT-FS, Ventana Medical Systems Inc, Tucson, AZ
| Date | Jan 24, 2008 (initiated Sep 29, 2006) |
| Status | Terminated |
| Reason | Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. |
| Root cause | Device Design |
| Action | The firm has mailed three customer letters, a) the first letter dated 9/30/2005 describes the upgraded Voila CD that contains safety information; b) a second letter, dated 6/27/2006, identified as a "Customer Alert" was mailed describing an upgrade to the software system version 9.3/10.3 and the CD that includes safety improvements, c) the third letter dated 9/29/2006 and identified as a Safety Alert advises that as part of their effort to continuously improve laboratory safety, they are updating the labeling and instructions for use regarding installation and cleaning for the carboy as the Ve |
| Quantity | USA - 1,712 units; Foreign - 1,159 units (total for recalls-Z-0537-0541-2008) |
| Distribution | Worldwide; USA, Australia, China, Canada, Germany, Great Britain, France, Italy, Hungary, Singapore, Korea, Taiwan, Spain, Poland, Greece, Austria, Sweden, Japan, Israel, Denmark, Turkey, Finland, Saudi Arabia, The Netherlands, Norway, Slovenia, Ireland, and Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.