Becton Dickinson Recalls BioGX SARS-CoV-2 Reagents for Sealed Tube Defect
Becton Dickinson is recalling BioGX SARS-CoV-2 Reagents for BD MAX System because rehydration buffer tubes were not adequately sealed, potentially causing unresolved test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect leads to unresolved test results rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Becton Dickinson & Co. is recalling 21,529 kits of BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test (Catalog Number: 444213). The recall covers lots distributed nationwide in the United States with expiration dates ranging from January 23, 2021, to May 17, 2021.
The recall was initiated because the rehydration buffer tubes were not adequately sealed. This defect caused some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX System.
Healthcare facilities and laboratories should stop using the affected reagents and contact Becton Dickinson for instructions on how to return the product.
The recalled product
- Product
- BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 21,529
Distribution
Distributed nationwide across the United States.
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