—#182586

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.

FDA product code: QJR — Reagents, 2019-Novel Coronavirus Nucleic Acid
Device class: Class N
Medical specialty: Unknown
Affected lot / code info: All lots are affected

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-07-20
Terminated: 2021-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182586. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.