BD Biosciences Recalls FMC7 FITC Reagent Due to Functional Degradation
Becton, Dickinson and Company is recalling FMC7 FITC reagents because functional degradation reduces the percent positive from 100% to approximately 87%.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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 III, which is defined as unlikely to cause adverse health consequences. The hazard is functional degradation affecting test accuracy, with no reported injuries or illnesses.
Plain-English summary
Becton, Dickinson and Company (BD) has initiated a recall of the FMC7 FITC (ASR) reagent, Catalog No. 340918. The recall involves 1,388 units distributed nationwide.
The recall was issued because the product is exhibiting functional degradation. This degradation reduces the percent positive from 100% down to approximately 87%. The affected lot numbers are 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, and 5182818.
The source text does not specify specific consumer actions or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 1,388
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 (9)
- Lot No. 4162520
- 4206855
- 4267919
- 4276818
- 4309977
- 5009530
- 5036624
- 5085573
- 5182818
Distribution
Distributed nationwide across the United States.
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