Recall Z-0086-2021 ยท KPA Slide Stainer, Automated
Roche Diagnostics Operations, Inc.
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
| Date | Aug 31, 2020 |
| Status | Open, Classified |
| Reason | Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket |
| Root cause | Device Design |
| Action | Roche issued Urgent Medical Device Correction letter on 8/31/20 via UPS Ground Receipt stating: reason for recall, health risk and action to take: actions below. " Inform any operators that use the BenchMark ULTRA and DISCOVERY ULTRA instruments of the potential hazards associated with this issue and provide a copy of this notification as appropriate. " Inspect the instrument daily for evidence of leaks (i.e., liquid outside of the waste reservoir, liquid on the floor, liquid on the skin/outer panel of the instrument). " If you experience a fluid leak, stop using the system and turn off the po |
| Quantity | 257 (US); 208 (ex-US) |
| Distribution | Nationwide Foreign: Canada, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.