Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BD MAX SARS-CoV-2 Reagents Recalled by Becton Dickinson & Co. Due to BD is experiencing elevated rates of potential false...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Becton Dickinson & Co. directly.
Affected Products
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.
Quantity: 30,392 to date
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Becton Dickinson & Co.
Becton Dickinson & Co. has 183 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report