Reported Aug 9, 2023 · Ongoing
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The…
Hamamatsu Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hamamatsu Corporation · 360 Foothill Rd · Bridgewater, NJ · 08807-2920
Is this the product you have?
- 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 NumberC13220-01MD
- Lot codes and dates
- UDI-DI010458238901065911220
- S/N90121100033
- Amount recalled
- 1 unit
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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