Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal… — Class II medical device recall Z-0521-2013
Terminated recall by Leica Microsystems, Inc., reported 2012-12-19, distributed in AR, CA, FL, IL, MD, MI, MN, MO…. RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.
| Recall number | Z-0521-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2012-11-14 |
| Classified | 2012-12-13 |
| Reported by FDA | 2012-12-19 |
| Terminated | 2017-11-29 |
| Distributed | AR, CA, FL, IL, MD, MI, MN, MO, NC, OR, RI, TN, TX, WI |
| Countries outside the US | CA |
| Quantity | 322 vials |
| Reason classes | labeling |
| Lot numbers | 2012-11, 2014-04, 6001845, 6009645, 804804, 804805, 804806, 804809, 804810, 804812 |
| Model numbers | RTU-TDT-339 |
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 for recall
RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0521-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.