Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.

FDA Recall Z-1446-2013 · Posted 2013-06-03

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeIDZ
Date Initiated2013-04-04
Date Terminated2017-07-21
Product Quantity20,160 units

Reason for Recall

An LPC Fine Mesh Cassette failed to stay closed during processing operations.

Firm Action

A Medical Device Correction letter dated April 17, 2013 was sent to customers via USPS 1st class mail. The product issue was described and recommended actions were provided. Customers were requested to acknowledge receipt of the letter by fax-back. Customer questions were directed to (847) 405-5413.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.

Official Source

View FDA Recall →

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

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