Data Foundry

Medical device recalls 2021

BOND Ready-To-Use Primary Antibody CDX2 — Class II medical device recall Z-2481-2021

Terminated recall by Leica Microsystems, Inc., reported 2021-09-22, distributed nationwide. Product may not perform as specified in IFU.

Recall numberZ-2481-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmLeica Microsystems, Inc., Buffalo Grove, IL, United States
Recall initiated2021-07-30
Classified2021-09-16
Reported by FDA2021-09-22
Terminated2023-06-22
DistributedNationwide (US)
Quantity237 units
Lot numbers69909
Model numbersPA0375

Product

BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375

Reason for recall

Product may not perform as specified in IFU.

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-2481-2021. 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.