The Recall Desk
ModerateFDA (Devices)·Z-2481-2021·Announced 2021-09-22

Leica BOND Primary Antibody CDX2 Recalled for Performance Specification Issue

Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (PA0375, Lot 69909) because the product may not perform as specified in its instructions for use. The recall affects 237 units distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II medical device with a performance specification issue and no reported illnesses, injuries, or deaths. The hazard is theoretical without evidence of actual patient harm.

Plain-English summary

Leica Microsystems, Inc. is recalling BOND Ready-To-Use Primary Antibody CDX2 (Product Code PA0375, Lot 69909). This is a diagnostic reagent used in laboratory testing, distributed nationwide throughout the United States.

The recall was issued because the product may not perform as specified in its instructions for use. This performance issue affects 237 units of the identified lot.

Healthcare providers and laboratory facilities that have received units of Lot 69909 should contact Leica Microsystems for guidance or information regarding the recalled product.

The recalled product

Product
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Manufacturer
Leica Microsystems, Inc.
Category
Medical Device — Diagnostic Reagent
Hazard
  • performance-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product Code PA0375
  • Lot 69909

Distribution

Distributed nationwide across the United States.

Related recalls

Same category