Recall Z-2023-2024— Becton Dickinson & Co.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2024-05-07. FDA's recall record names no specific 510(k) clearance for this event. Product: BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.. Reason: Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-07
- Firm location
- Sparks, MD, United States
Product description
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Reason for recall
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.