Recall Z-2529-2024 ยท IDW Dispensers, Paraffin
LEICA BIOSYSTEMS NUSSLOCH GMBH
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
| Date | Aug 7, 2024 (initiated May 10, 2024) |
| Status | Open, Classified |
| Reason | An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank. |
| Root cause | Device Design |
| Action | The recalling firm issued letters dated 4/30/2024 via email on 5/10/2024. The letter provided the model and serial number of the devices involved, a description of the problem, and immediate actions to be taken. The consignee is to check to see if they have one of the affected instruments and determine whether the Arcadia H is in active use in the facility. If it is, the consignee is to discontinue the use of it immediately and disconnect it from main voltage. If it has not been decommissioned at the time of receipt of the letter, the consignee is to reach out to their sales representative |
| Quantity | 180 devices |
| Distribution | US Nationwide, including government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.