Data Foundry

Medical device recalls 2016

Novocastr Liquid Mouse Monoclonal Antibody CDX2 — Class II medical device recall Z-1877-2016

Terminated recall by Leica Microsystems, Inc., reported 2016-06-08, distributed in AR, CA, CT, FL, ID, IL, IN, MT…. Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on

Recall numberZ-1877-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmLeica Microsystems, Inc., Buffalo Grove, IL, United States
Recall initiated2016-04-05
Classified2016-06-01
Reported by FDA2016-06-08
Terminated2017-11-30
DistributedAR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN, TX
Countries outside the USCA
Quantity90 units
Reason classeslabeling
Lot numbers6032734, 6033766, 6037153, 6039088

Product

Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.

Reason for recall

Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.

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-1877-2016. 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.