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Class 2 Device Recall BD MAX Instrument Reader hardware |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
September 24, 2018 |
Create Date |
October 31, 2018 |
Recall Status1 |
Terminated 3 on April 10, 2020 |
Recall Number |
Z-0313-2019 |
Recall Event ID |
81145 |
Product Classification |
Vaginitis and bacterial vaginosis nucleic acid detection system - Product Code PQA
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Product |
BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - 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: CTI1201-CTI1288 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems Sparks MD 21152-9212
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For Additional Information Contact |
Customer/Technical Support 800-638-8663
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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.
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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 |
49 |
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
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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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