Recall archive
74 recalls · page 2 of 4
Reported Apr 14, 2021
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a…
FDA (openFDA device enforcement)
Reported Jan 6, 2021
BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2020
BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX…
FDA (openFDA device enforcement)
Reported May 27, 2020
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2019
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2019
Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
18 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2019
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2019
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
FDA (openFDA device enforcement)
Reported Mar 13, 2019
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and…
FDA (openFDA device enforcement)
Reported Mar 6, 2019
Phoenix AST-s Indicator, Catalog Number 246009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 12, 2018
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
FDA (openFDA device enforcement)
Reported Nov 7, 2018
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 17, 2018
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Becton Dickinson & Co.
Matched: Brand — The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating…
FDA (openFDA device enforcement)
Reported Aug 29, 2018
BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product…
FDA (openFDA device enforcement)
Reported May 9, 2018
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Becton Dickinson & Co.
Matched: Brand — The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 21, 2018
Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — HighPuragar was mislabeled and inadvertently sold as Noble Agar.
FDA (openFDA device enforcement)
Reported Jan 31, 2018
BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2017
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Listeria monocytogenes contamination of non-sterile plated media
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 6, 2017
BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb)…
FDA (openFDA device enforcement)
Reported May 3, 2017
BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Becton Dickinson & Co.
Matched: Brand — BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza…
FDA (openFDA device enforcement)
Reported Mar 15, 2017
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some…
FDA (openFDA device enforcement)
Reported Mar 8, 2017
BD AffirM VPIII Microbial Identification Test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the…
FDA (openFDA device enforcement)
Reported Dec 28, 2016
BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath¿…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can…
FDA (openFDA device enforcement)
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