BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasophary
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Co. is recalling 938 kits of BioGX SARS-CoV-2 Reagents for BD MAX System (catalog number 444213) distributed nationwide. Some N1 and N2 master mix pouches within affected lots may be mislabeled, resulting in kits containing two pouches of the same type (either two N1 or two N2) instead of one of each. The affected lot numbers are K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, and K21-021.
If laboratory personnel do not notice that both pouches have the same color foil seal and use two tubes of the same type, there is a low potential for false negative SARS-CoV-2 results. A false negative result could increase the risk of disease progression for the patient and additional spread of the virus if the patient is not quarantined. The source does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.
Reason for recall: Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined. Distribution: US nationwide distribution. Quantity: 938 kits Lot/code info: Catalog Number: 444213, Lot Numbers: K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, K21-021. GTIN Number: 00382904442132
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.