Novocastra Ready-to-Use Mouse Monoclonal Antibody recall: Labeling Error
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. RTU-TdT-339 is intended for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Why was Novocastra Ready-to-Use Mouse Monoclonal Antibody recalled?
RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No. RTU-TdT-339, lot numbers 6001845, expiry 2012-11 and 6009645, expiry 2014-04 The recall also included the folowing expired lots: 804804, 804805, 804806, 804809, 804810, 804812
- Product
- Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. RTU-TdT-339 is intended for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
- Recalling firm
- Leica Microsystems, Inc.
- Quantity
- 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 country of Canada.
- Recall date
- December 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)