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Open, Classified

Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01

FDA Recall Z-1247-2025 · Posted 2025-02-27

Recalling FirmLEICA BIOSYSTEMS NUSSLOCH GMBH
Recall StatusOpen, Classified
Product CodeIDP
Date Initiated2025-01-30
Product Quantity2

Reason for Recall

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

Firm Action

On January 30, 2025, the firm notified customers through Email of the recall. Customers were provided with immediate actions to take to mitigate the risk of damaging the tissue sample. Among the firm's recommendations was to have a backup instrument if available. The firm's Service organization will contact customers in the coming weeks to organize the upgrade of affected instruments.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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