Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro sta

FDA device recall Z-0521-2013 · posted 2012-12-13 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.

Action taken

Leica Microsystems, Inc. sent a Product Recall Notification letter dated November 14, 2012, via first class mail on the same date, to all affected customers. The letter identified the product ,the problem, and the actions to be taken by the customers. Customers were instructed to discontinue use of the product and to return any unused/part used reagents to the Richmond, IL, location for replacement. The accounts were asked to complete the attached Acknowledgement Form, acknowledging receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-236-3747. Additional questions should be addressed to the account's Leica Representative.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NJT

Quantity affected

322 vials

Distribution

Worldwide Distribution -- USA including Arkansas, California, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Rhode Island, Tennessee, Texas and Wisconsin, and the

Date initiated

2012-11-14

Date posted

2012-12-13

Date terminated

2017-11-29

Location

Buffalo Grove, IL