Becton Dickinson Recalls BioGX SARS-CoV-2 Reagents Due to Mislabeled Pouches
Becton Dickinson is recalling 938 kits of BioGX SARS-CoV-2 Reagents because some master mix pouches may be mislabeled, potentially leading to false negative test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product (medical diagnostic) where a false negative could lead to disease progression and spread, but the source explicitly states there is a 'low potential' for this error and no injuries or illnesses have been reported.
Plain-English summary
Becton Dickinson & Co. is recalling 938 kits of BioGX SARS-CoV-2 Reagents for BD MAX System (Catalog Number 444213). The affected lots are K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, and K21-021. The products were distributed nationwide in the United States.
The recall was issued because some N1 and N2 master mix pouches within these lots may be mislabeled. This error could result in a kit containing two pouches of the same master mix type instead of one 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 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. The source text does not specify specific actions for consumers, as the product is an in vitro diagnostic intended for use by healthcare providers.
The recalled product
- Product
- 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…
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 938
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 (8)
- Catalog Number: 444213
- Lot Numbers: K20-507
- K20-508
- K20-509
- K20-516
- K20-517
- K21-020
- K21-021. GTIN Number: 00382904442132
Distribution
Distributed nationwide across the United States.
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