—#158667

Product

BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing

FDA product code: JQX — Nephelometer, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Serial Numbers: AP0447, AP0448, AP0449, AP0450, AP0451, AP0458 & AP0463.

Why it was recalled

Potential unexpected movement of robot arm

Root cause (FDA determination)

Process control

Action the firm took

BD Diagnostic Systems telephoned all customers on June 1, 2017 and sent an Urgent Product Recall letter dated May 31, 2017, and Response Forms to their customers via email. BD recently confirmed a manufacturing issue with the motor that drives movement of the robot arm. The issue may result in the inability of this motor to withstand the lateral forces encountered during normal operations. Should this occur, the instrument will indicate an E20 error-Pipettor step loss during operation and stop functioning. While there is no loss of patient sample, the samples would need to be manually processed until the instrument can be repaired. To limit any disruption in the workload, BD Service will contact customers to schedule the instrument replacement. Customers are advised to complete and return the response form via email to BDRC2@aol.com. Customers may continue to use the instrument until replacement is performed. Customers with questions may contact BD (Customer/Technical) Support at 1-800-638-8663. For questions regarding this recall call 410-316-4258.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Worldwide Distribution - US including CA, NC & TN Internationally: Canada

Timeline

Recall initiated: 2017-06-01
Terminated: 2018-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158667. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.