FDA Device recall Z-0521-2013
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent
- FDA Device
- Class II
- terminated
- Published 2012-12-19
On 2012-12-19 the FDA classified a Class II recall of Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent by Leica Microsystems, citing RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0521-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-14 |
| Published | 2012-12-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Leica Microsystems |
| Distribution | AR, CA, FL, IL, MD, MI, MN, MO, NC, OR, RI, TN, TX, WI |
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.
Reason
RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.
Identifiers
| code_info | Catalog No. RTU-TdT-339, lot numbers 6001845, expiry 2012-11 and 6009645, expiry 2014-04 The recall also included the…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0521-2013%22
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