BD SARS-CoV-2 Reagent Kits Recalled for False Negative Test Results
Becton Dickinson is recalling 2,061 kits of BD SARS-CoV-2 Reagents for BD MAX Systems because they may produce false negative results due to decreased enzyme activity. The kits were distributed nationwide and internationally.
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: This Class II recall presents a risk-of-harm scenario through potential diagnostic failure, with false negative results that could allow undetected infections. No illnesses, injuries, or deaths have been reported, placing it at the maximum score permitted for theoretical hazards without documented harm.
Plain-English summary
Becton Dickinson & Co. is recalling BD SARS-CoV-2 Reagents for BD MAX Systems, an RT-PCR diagnostic test used to detect SARS-CoV-2 virus in nasal, nasopharyngeal, oropharyngeal swab, and saliva specimens. The recall involves 2,061 kits.
The reagents may produce false negative results due to decreased activity of the enzyme used in manufacturing. A false negative result means the test may fail to detect the virus in specimens from infected individuals.
The affected kits were distributed nationwide in the United States as well as internationally to Australia, Brazil, Belgium, Canada, Colombia, and Japan. The specific affected lot numbers are 3291356 (expiration 8/3/24), 3291358 (expiration 11/19/24), and 3326001 (expiration 12/17/24).
The recalled product
- 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.
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 2,061
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 (7)
- Catalog No. 445003-01
- UDI-DI: (01) 60382904450030 (17) 240803 (10) 3291356 (20) 01 (30) 1
- (01) 60382904450030 (17) 241119 (10) 3291358 (20) 01 (30) 1
- (01) 60382904450030 (17) 241217 (10) 3326001 (20) 01 (30) 1
- Lot No. 3291356 (Exp. 8/3/24)
- 3291358 (Exp. 11/19/24)
- 3326001 (Exp. 12/17/24).
Distribution
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