BD PCR Cartridges for MAX System signal drift in select lots

Plain-English summary

Becton Dickinson & Co. is recalling specific lots of BD PCR Cartridges (Model 437519) used with the MAX System. A total of 516,435 units have been identified as part of this recall, which affects cartridges distributed worldwide and throughout the United States.

The recall addresses a potential for signal drift in these cartridges. Signal drift means the cartridge readings may become inaccurate or unreliable over time, which could affect the accuracy of diagnostic test results.

The affected cartridges were distributed to healthcare facilities, laboratories, and diagnostic centers worldwide, including facilities in numerous U.S. states and countries such as Canada, Australia, Japan, India, and others.

Customers who have received these cartridges should contact Becton Dickinson & Co. for instructions on how to identify affected units and for guidance on appropriate next steps. Healthcare providers should consult with their laboratory directors regarding any necessary actions to ensure diagnostic accuracy.

The recalled product

Product

BD PCR Cartridges used with MAX System. Model Number: 437519

Manufacturer

Becton Dickinson & Co.

Category

Medical Device — Diagnostic Equipment

Hazard

• signal-drift
• diagnostic-inaccuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

Related recalls