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U.S. Department of Health and Human Services

Class 2 Device Recall BD MAX Instrument Reader hardware

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  Class 2 Device Recall BD MAX Instrument Reader hardware see related information
Date Initiated by Firm September 24, 2018
Create Date October 31, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-0312-2019
Recall Event ID 81145
Product Classification Vaginitis and bacterial vaginosis nucleic acid detection system - Product Code PQA
Product BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
Code Information Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 78387, 78182, 78832, 78905, 77062, 78856, 78352, 78903, 78667, 78665, 78928, 78986, 77108, 77543, 78615, 78481, 77373, 77707, 78927
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
BD Diagnostic Systems
Sparks MD 21152-9212
For Additional Information Contact Customer/Technical Support
800-638-8663
Manufacturer Reason
for Recall		 A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Urgent Medical Device Product Recall notification letters dated 9/24/18 were sent to customers.
Quantity in Commerce 23
Distribution Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. Countries of Spain, Germany, France, Austria, Denmark, Switzerland, Sweden, Italy, Kuwait, Oman, Saudi Arabia, and Turkey.
Total Product Life Cycle TPLC 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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