BD Anti-Kappa Flow Cytometry Reagents Recalled for Uncharacteristic Flow Profiles
BD Anti-Kappa APC and PE reagents used in flow cytometry testing may exhibit uncharacteristic flow profiles, potentially affecting test accuracy. Worldwide distribution to 249 units across US states and Taiwan.
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: This is an FDA Class II recall of a diagnostic reagent with a performance issue. No illnesses or injuries have been reported. The hazard is diagnostic inaccuracy rather than direct biological danger, consistent with a voluntary precautionary recall.
Plain-English summary
Becton, Dickinson and Company is recalling BD Anti-Kappa APC (Cat. No. 341098), an analyte specific reagent used in flow cytometry laboratories for identifying cells expressing kappa light chains of human immunoglobulins. The recall also includes the PE formulation of the same reagent.
The recalled reagents may exhibit uncharacteristic flow profiles, which could affect the accuracy and reliability of flow cytometry test results. Uncharacteristic flow profiles may lead to incorrect cell identification or quantification.
The affected product (Lot #1064663) has been distributed worldwide, including across 28 US states (Alabama, California, Colorado, District of Columbia, Delaware, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia) and Taiwan. A total of 249 units were distributed.
Healthcare facilities and laboratories that have received this product should stop using affected units and contact BD Biosciences. Facilities should review any test results generated using affected reagent lots to determine whether re-testing may be necessary.
The recalled product
- Product
- BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow…
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 249
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)
- Lot # 1064663
- UDI: 00382903410989
Distribution
Part of a larger recall action
This product is one of 2 recalled by Becton, Dickinson and Company, BD Biosciences under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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