BD MAX MRSA Reagent Kit Recall Due to Improperly Sealed Foil Bags
Becton Dickinson is recalling 176 units of BD MAX MRSA Reagent Kits because foil bags containing extraction tubes may not have been sealed properly.
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 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 II, and the source text does not report any illnesses, injuries, or specific health hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 176 units of the BD MAX MRSA Reagent Kit (Catalog # 442953). The recall is due to a manufacturing defect where the foil bags containing the extraction tubes may not have been sealed properly.
The affected product is identified by Lot # 9071522 and has an expiration date of 12/19/2019. The distribution pattern includes numerous U.S. states and territories, as well as international locations including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
The source text does not specify specific consumer actions or report any illnesses or injuries associated with this defect. The agency classification for this recall is Class II.
The recalled product
- Product
- Kit BD Max MRSA; Catalog # 442953
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 176
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 (4)
- Lot # 9071522
- UDI (GTIN
- DI+PI): (01)00382904429539 (17)191219(10)9071522(30)1
- Exp :12/19/2019
Distribution
Part of a larger recall action
This product is one of 19 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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