Recall archive
74 recalls · page 3 of 4
Reported Nov 2, 2016
PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Becton Dickinson & Co.
Matched: Brand — BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 4, 2016
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile…
FDA (openFDA device enforcement)
Reported Dec 30, 2015
Vancomycin Screen Agar
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2015
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on…
FDA (openFDA device enforcement)
Reported Jun 17, 2015
BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2015
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood,…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2014
BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Agar that allows…
FDA (openFDA device enforcement)
Reported Sep 17, 2014
The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven…
FDA (openFDA device enforcement)
Reported Jul 23, 2014
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Becton Dickinson & Co.
Matched: Brand — A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect…
FDA (openFDA device enforcement)
Reported Feb 5, 2014
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2014
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for…
FDA (openFDA device enforcement)
Reported Oct 30, 2013
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false…
FDA (openFDA device enforcement)
Reported Sep 4, 2013
PrepStain AG. For use in the screening and detection of cervical cancer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2013
BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand · Product details — In vitro diagnostic test kit may exhibit invalid internal negative control results.
FDA (openFDA device enforcement)
Reported Jul 31, 2013
BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand · Product · Product details — Microbiological identification media may exhibit reduced levels of Vancomycin.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2013
BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Becton Dickinson & Co.
Matched: Brand — Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
FDA (openFDA device enforcement)
Reported Jun 5, 2013
BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 22, 2013
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Microbiological media may be contaminated with bacteria.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 15, 2013
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand · Product details — Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
FDA (openFDA device enforcement)
Reported Apr 3, 2013
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
FDA (openFDA device enforcement)
Reported Feb 6, 2013
BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand · Product · Product details — Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
FDA (openFDA device enforcement)
Reported Jan 30, 2013
Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand · Product · Product details — In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2012
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand · Product · Product details — An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
FDA (openFDA device enforcement)
Reported Dec 19, 2012
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand · Product · Product details — In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus…
FDA (openFDA device enforcement)
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