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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Hazard
- Affected units
- 237
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.
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