Becton Dickinson & Co.: Device Recall

Recall Details

Recall Number

Z-2585-2024

Classification

Class II

Product Type

Device

Recalling Firm

Becton Dickinson & Co.

Status

Ongoing

Date Initiated

07/09/2024

Location

Sparks, MD, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

23 units

Reason for Recall

There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.

Product Description

BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;

Distribution Pattern

US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.

Other Recalls by Becton Dickinson & Co.

• Class II: Risk 10/23/2025
  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.
• Class II: Risk 09/23/2025
  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.
• Class II: Risk 09/23/2025
  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.
• Class II: Risk 09/23/2025
  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.
• Class II: Risk 09/23/2025
  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.

View all recalls by Becton Dickinson & Co. →