BD Max MRSA XT Extraction Tube Sealing Defect Recall
Becton Dickinson is recalling BD Max MRSA XT 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 describes a potential sealing defect without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving potential risks without confirmed harm.
Plain-English summary
Becton Dickinson & Co. is recalling 61 units of the BD Max MRSA XT kit (Catalog # 443461). The recall involves specific lots with expiration dates in August and September 2020.
The recall was initiated because the foil bags containing the extraction tubes for the BD MAX Reagent products may not have been sealed properly. This defect could potentially affect the integrity of the reagents.
The affected products were distributed to various states in the United States and to several countries worldwide, including Australia, Canada, and Japan. Users of these kits should stop using the affected lots and contact Becton Dickinson for further instructions.
The recalled product
- Product
- Kit BD Max MRSA XT; Catalog # 443461
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 61
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)
- Lot # 9106890
- UDI (GTIN
- DI+PI) :(01)00382904434618 (17)200828(10)9106890(30)1
- Exp :8/28/2020 Lot # 9106891
- DI+PI) :(01)00382904434618 (17)200909(10)9106891(30)1
- Exp :9/9/2020 Lot # 9114657
- DI+PI) :(01)00382904434618 (17)200922(10)9114657(30)1
- Exp : 9/22/2020
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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