Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

FDA device recall Z-2529-2024 · posted 2024-08-07 · Open, Classified

Recall details

Recalling firm

LEICA BIOSYSTEMS NUSSLOCH GMBH

Reason for recall

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.

Action taken

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. The sales representative will work with the consignee to determine the disposition of the device according to their local regulations. The consignee is requested to pass the notification letter to users of the device and to all within their organization who need to know. The consignee is to confirm receipt of the letter within 5 days by completing the attached acknowledgement form and returning a scanned copy via email.

Root cause

Device Design

Status

Open, Classified

Product code

IDW

Quantity affected

180 devices

Distribution

US Nationwide, including government distribution.

Date initiated

2024-05-10

Date posted

2024-08-07

Location

Nussloch, Germany