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U.S. Department of Health and Human Services

Class 3 Device Recall BC Phoenix AP

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 Class 3 Device Recall BC Phoenix APsee related information
Date Initiated by FirmJune 01, 2017
Create DateDecember 06, 2017
Recall Status1 Terminated 3 on May 09, 2018
Recall NumberZ-0198-2018
Recall Event ID 78102
Product Classification Nephelometer, for clinical use - Product Code JQX
ProductBD 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
Code Information Serial Numbers: AP0447, AP0448, AP0449, AP0450, AP0451, AP0458 & AP0463.
FEI Number 1119779
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information ContactGail Griffiths
410-316-4258
Manufacturer Reason
for Recall		Potential unexpected movement of robot arm
FDA Determined
Cause 2		Process control
ActionBD 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.
Quantity in Commerce7 units
DistributionWorldwide Distribution - US including CA, NC & TN Internationally: Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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