FDAJune 6, 2023device
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient.
What to do
FDA enforcement status: Ongoing
Brands named
hamamatsu
UPCs
90121100033
Recall history
No related federal recalls on record for this brand yet.
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