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U.S. Department of Health and Human Services

Class 2 Device Recall BD MAX SARSCoV2 Reagents

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  Class 2 Device Recall BD MAX SARSCoV2 Reagents see related information
Date Initiated by Firm July 20, 2020
Create Date August 04, 2020
Recall Status1 Terminated 3 on July 13, 2021
Recall Number Z-2754-2020
Recall Event ID 86061
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
Code Information All lots are affected
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact BD Customer/Technical Support
800-638-8663
Manufacturer Reason
for Recall		 BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.
FDA Determined
Cause 2		 Under Investigation by firm
Action On July 20, 2020, the firm sent Urgent Medical Device Product Advisory letters to their customers. Customers were informed that all lots are impacted by the elevated rates of potential false positive results. Customers were advised that all positive results are considered presumptive. BD recommends that testing for any positive samples be repeated using an alternate authorized test method. Customers were asked to share the notification with all users of the reagents within their facility to ensure that they are also aware of this product advisory. Customers are to complete and return the customer response form to the recalling firm. US customers who require further assistance may contact BD Customer/Technical Support at 800-638-8663, Monday-Friday, between 7AM-7PM (EST). OUS customers may contact their local BD representative or distributor.
Quantity in Commerce 30,392 to date
Distribution Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GU, HI, IL, IN, KY, MD, MI, MO, NC, NJ, NY, PA, SC, TN, TX, WI, WY and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Hong Kong, Japan, Mexico, New Zealand, Peru, Philippines, Singapore.
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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