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Leica CV5030

Leica Biosystems Nussloch GmbH · Model 000000014047839700 · UDI-DI 04049188051035

KIM
1
510(k) clearances
10
Adverse events
1
Recalls
12
Facilities

Description

The Leica CV5030 is a robotic coverslipper for coverslipping tissue sections, cells or swabs mounted on specimen slides with cover slips made out of glass using a wide variety of different cover slip mountants. It may only be used with instrument accessories approved by Leica Biosystems Nussloch GmbH.

Recalls

DateFirmReason
2018-09-04Leica Microsystems, Inc.Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.