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Leica Biosystems Imaging recalls

Leica Biosystems Imaging has 2 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 16 Oct 2019. The most frequent reason is device malfunction.

Total recalls2since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 16 Oct 2019

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why leica biosystems imaging is recalled

Device Malfunction150%
Foreign Material150%

Product types

Other Medical Devices150%
Patient Monitors150%

By year

2019150%
2014150%

All leica biosystems imaging recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
16 Oct 2019Device	CLASS II	Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE recalled	Leica Biosystems Imaging	Device Malfunction	CA
19 Mar 2014Device	CLASS II	HER2 Image Analysis Manual Read of HER2 Digital Slides recalled	Leica Biosystems Imaging	Foreign Material	12 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.