Recall

becton dickinson & co.

10 recalls on record

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Becton Dickinson & Co. — BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

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Becton Dickinson & Co. — BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

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Becton Dickinson & Co. — BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;

The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

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Becton Dickinson & Co. — BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

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Becton Dickinson & Co. — BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

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Becton Dickinson & Co. — BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

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Becton Dickinson & Co. — BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

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Becton Dickinson & Co. — BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPAR

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

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Becton Dickinson & Co. — BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number:

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

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Becton Dickinson & Co. — BD COR System Software. Model Number: 444829.

Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.