BD MAX SARS-CoV-2 Reagents Recalled for Potential False Positive Results
Becton Dickinson is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results, which could delay diagnosis and increase exposure risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (delayed diagnosis and potential exposure to infection) where specific injury or death has not been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Becton Dickinson & Co. is recalling BD MAX SARS-CoV-2 Reagents, Catalog Numbers 445003 and 445003-01, due to elevated rates of potential false positive results reported by certain customers. The product is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in various swab and aspirate specimens from individuals suspected of COVID-19.
The recall covers 30,392 units distributed worldwide, including nationwide distribution in the United States and in several international countries. All lots are affected. The agency has classified this as a Class II recall.
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. Healthcare providers and laboratories should stop using the affected reagents and contact Becton Dickinson for further instructions.
The recalled product
- 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, nasophar
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 30,392
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots are affected
Distribution
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