Recall Z-1919-2024 ยท KPA Slide Stainer, Automated
Agilent Technologies
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
| Date | May 29, 2024 (initiated Apr 2, 2024) |
| Status | Open, Classified |
| Reason | There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury. |
| Root cause | Device Design |
| Action | On April 15, 2024, Agilent Technologies, issued a "Urgent Medical Device Correction" notification to affected consignees. Agilent asked consignees to take the following actions: 1. Monitor your device and contact the service organization in case you discover a problem with the plexiglass on the lower front door. - In case the plexiglass of the lower front door is broken, immediately cease operation of the instrument - Do not remove the lower front door assembly, and do not run the instrument without the cover2.Confirm that you have received this information by signing and returning enclos |
| Quantity | 1160 devices |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, TN, MI, MD, MA, OR, AK, MO, NC, NH, GA, RI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Spain, Italy, Japan, Malaysia, Netherland, New Zealand, Nor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.