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.
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 3/5 (High).
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…
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 199
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
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Becton, Dickinson and Company, BD Biosciences
See all →- HighBD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results
FDA (Devices) · 2024-07-24
- HighMedical diagnostic reagent recall: incorrect cell staining fluorescence
FDA (Devices) · 2024-01-17
- HighBD Trucount Tubes for Blood Testing Recall Due to Label Detachment
FDA (Devices) · 2022-11-09
- HighBD Trucount Tubes Recalled Due to Partial Label Detachment Causing Operational Failures
FDA (Devices) · 2022-11-09
- ModerateBD Multitest 6-Color TBNK tubes recalled for partial label detachment
FDA (Devices) · 2022-11-09
Same hazard · diagnostic error
See all →- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
Similar recalls
- ModerateBD Multi-Check CD4 Low Control Recalled for Inaccurate Flow Cytometry Results
FDA (Devices) · 2020-12-16
- HighBD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts
FDA (Devices) · 2019-10-16
- HighBD FACSLyric Flow Cytometer Recalled for Potential False Absolute Counts
FDA (Devices) · 2019-10-16
- HighBD FACSLyric Flow Cytometer Recall for Potential False High Absolute Counts
FDA (Devices) · 2019-10-16
- HighBD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results
FDA (Devices) · 2024-07-24
- HighBD FACSLyric Flow Cytometer Recall for Potential Inaccurate Cell Counts
FDA (Devices) · 2019-10-16