Becton Dickinson & Co.: Device Recall

Recall Details

Recall Number

Z-2686-2024

Classification

Class II

Product Type

Device

Recalling Firm

Becton Dickinson & Co.

Status

Ongoing

Date Initiated

07/18/2024

Location

Sparks, MD, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

12,383 eaches

Reason for Recall

May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.

Product Description

BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brunei, Brazil, Canada, China, Costa Rica, Dominican Republic, Guatemala, Guyana, Hong Kong, Haiti, Indonesia, India, Japan, Korea, Myanmar, Macau, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, El Salvador, Thailand, Trinidad and Tobago, Taiwan, Vietnam.

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. →