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Terminated

Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.

FDA Recall Z-1704-2016 · Posted None

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeNJT
Date Initiated2016-03-22
Date Terminated2017-11-30
Product Quantity290 units

Reason for Recall

Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.

Firm Action

A Medical Device Recall Notification letter was sent via e-mail on April 5, 2015 to the consignees describing the nature of the recall and action that needed to be taken. The firm requested that the consignees take the following actions: Only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the lot numbers of diluent specified. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. Complete and return the attached acknowledgment. The firm requests that consignees contact their local Leica representative if they have any questions or concerns, or alternatively please contact the firm at the following e-mail address; [email protected]

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.

Official Source

View FDA Recall →

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

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