medical Class II Updated 2020-08-12

Becton Dickinson & Co. recalls BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots are affected
View official government recall

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