RecallRadar

FDA Device recall Z-1877-2016

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

On 2016-06-08 the FDA classified a Class II recall of Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues by Leica Microsystems, citing testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1877-2016
ClassificationClass II
Statusterminated
Initiated2016-04-05
Published2016-06-08
Last updated2026-09-13 11:54 UTC
CompanyLeica Microsystems
DistributionAR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN, TX

Product

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

Reason

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

Identifiers

code_info1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1877-2016%22

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