Becton Dickinson & Co. — Class II: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Becton Dickinson & Co. initiated a Class II recall for certain lots of the BD GasPak EZ CO2 Pouch System (Catalog Number 260684) due to gas-generating sachets producing carbon dioxide levels below the required specification.
This affects Becton Dickinson & Co., microbiology laboratories utilizing the GasPak EZ system for microorganism cultivation, and clinical diagnostic departments relying on specific atmospheric conditions for testing.
Sub-specification carbon dioxide levels in gas-generating systems can potentially lead to suboptimal growth conditions for specific microorganisms. This suggests a risk of false-negative results or delayed diagnosis in a clinical microbiology setting, necessitating a review of lot-specific performance data and internal quality control protocols.
QA and Laboratory Managers should identify and quarantine affected lots of Catalog Number 260684. Regulatory teams should monitor for updated instructions for use or replacement sachets to ensure diagnostic performance is maintained.
Class II. Reason: 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.. Product: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use. Firm: Becton Dickinson & Co. (Sparks MD United States). Status: Ongoing.
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