BD Mouse IgG2a Antibody Reagent Recalled for Manufacturing Contamination
This antibody reagent was recalled due to manufacturing contamination that may produce false positive staining results in laboratory tests. The affected lot was distributed worldwide.
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 a Class II medical device recall involving a manufacturing quality control defect that compromises test accuracy through antibody contamination. No injuries or illnesses have been reported, and the hazard is theoretical (false positive staining), placing it at the Moderate severity level per the rubric.
Plain-English summary
The BD Mouse IgG2a Isotype Control APC X39 ASR is a laboratory antibody reagent used in research and testing. Manufactured by Becton, Dickinson and Company (BD Biosciences), it is supplied as a kit containing 23 reagents.
Complaints have been received regarding performance issues characterized by high background and staining. The root cause is a manufacturing process error that led to contamination of the affected lot with another antibody, potentially causing false positive staining results.
The affected lot (Lot Number 0253432, Catalog Number 340757, UDI 00382903407576) was distributed worldwide. In the United States, distribution occurred in Connecticut, Florida, Kentucky, New York, and Pennsylvania. The product was also distributed to Taiwan.
The recalled product
- Product
- BD" Mouse IgG2a Isotype Control APC X39 ASR
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Category
- Medical Device
- Affected units
- 23
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 (1)
- Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432
Distribution
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 · contamination
See all →- ModerateSafecor Health Recalls Metoclopramide Tablets Due to Co-Mingled Tablets
FDA (Drugs) · 2026-11-04
- ModeratePentax Medical Water Bottle Assembly Recalled for Sterile Water Warnings
FDA (Devices) · 2026-11-04
- SevereAVID Medical Recalls Halyard Anterior Hip Packs Due to Sterilization Error
FDA (Devices) · 2026-10-28
- SevereGreiner VACUETTE Blood Collection Tubes Recalled for EDTA Contamination
FDA (Devices) · 2026-10-28
- SevereFDA Recalls Argatroban Injection Vials Due to Particulate Matter
FDA (Drugs) · 2026-10-28
Similar recalls
- ModerateBD CD64 APC-R700 Reagent Recalled Due to CD4 Antibody Contamination
FDA (Devices) · 2015-12-02
- ModerateBD Biosciences Recalls Contaminated CD79b PE Antibody Reagent
FDA (Devices) · 2016-10-26
- ModerateBD CD56 PE Cy 7 Reagent Recalled for Unexpected Staining Patterns
FDA (Devices) · 2015-09-02
- HighBD BBL Gram Stain Kit Recalled for Potential False-Positive Results
FDA (Devices) · 2020-05-27
- HighBD SARS-CoV-2 Reagent Kits Recalled for False Negative Test Results
FDA (Devices) · 2024-06-12
- ModerateLeica Bond Polymer Refine Red Detection Kits Recalled for Staining Errors
FDA (Devices) · 2016-02-24