BD Anti-Kappa PE Flow Cytometry Reagent May Show Inaccurate Results
Becton Dickinson is recalling 199 units of BD Anti-Kappa PE flow cytometry reagent because samples may exhibit uncharacteristic flow profiles that could affect test accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall for a diagnostic reagent with potential for inaccurate test results. The source reports no illnesses or injuries. Per the rubric, this qualifies as High (3): a risk-of-harm diagnostic product where injury has not yet been reported.
Plain-English summary
BD Anti-Kappa PE (catalog number 346587) is a laboratory reagent used in flow cytometry to identify immune cells. Becton Dickinson is recalling 199 units of lot 1228977 because the reagent may show uncharacteristic flow profiles that could affect the accuracy of diagnostic test results.
The product was distributed worldwide, including throughout the United States—Alabama, California, Colorado, Washington DC, 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—as well as Taiwan. The UDI for the affected lot is 00382903465873.
Healthcare laboratories and hospitals using this product should contact Becton Dickinson for guidance regarding the affected lot and next steps.
The recalled product
- Product
- BD Anti-Kappa PE (Cat. No. 346587) 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 cytom
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Hazard
- diagnostic-error
- test-inaccuracy
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 # 1228977
- UDI: 00382903465873
Distribution
Distributed nationwide across the United States.
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