BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Test Results
Becton Dickinson is recalling the BD MAX Vaginal Panel due to an increased rate of unresolved and indeterminate results, which may require repeat testing.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is limited to non-reportable test results requiring repeat testing.
Plain-English summary
Becton Dickinson & Co. is recalling the BD MAX Vaginal Panel, a medical device used for the collection and transport of vaginal and endocervical swab specimens and the preservation of urine. The recall involves catalog numbers 443712, 443710, and 443711. The product was distributed in the United States and outside the United States.
The recall was initiated because the manufacturer notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the device. These non-reportable results may lead to the need for repeat testing and/or re-collection of specimens.
The source text does not specify the number of affected units or report any illnesses or injuries. Consumers and healthcare providers should contact Becton Dickinson & Co. for further instructions regarding the recall.
The recalled product
- Product
- BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Becton Dickinson & Co. 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 3 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Co.
See all →- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateLaboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
- HighAutomated microbiology systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighBlood culture systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateBecton Dickinson Recalls BD Max Vaginal Panel Kits Due to Seal Defects
FDA (Devices) · 2019-08-28
- HighBD MAX Enteric Bacterial Panel Recalled for False Negative Results
FDA (Devices) · 2019-03-13
- HighBD Max Instrument Recall for False Positive Candida Results
FDA (Devices) · 2018-11-07
- ModerateBD MAX Enteric Bacterial Panel Extraction Tube Sealing Defect Recall
FDA (Devices) · 2019-08-28
- ModerateBD Vacutainer Urine Collection Cups Recalled for Potential RBC Count Elevation
FDA (Devices) · 2018-11-28
- LowBD MAX Instrument Recall for Non-Compliant Electrical Power Module
FDA (Devices) · 2013-07-10