Becton Dickinson Recalls BD MAX Reagent Extraction Tubes Due to Sealing Defect
Becton Dickinson is recalling 715 units of the Kit EXT Enteric Bacterial Panel 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 or injuries, indicating a theoretical risk of harm rather than a confirmed adverse event.
Plain-English summary
Becton Dickinson & Co. is recalling 715 units of the Kit EXT Enteric Bacterial Panel (Catalog # 443812). The recall is due to a defect where the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly.
The affected lots are 9114557, 9126778, and 9129979. These products were distributed to 38 U.S. states, Puerto Rico, and several international locations including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect. The agency has classified this as a Class II recall.
The recalled product
- Product
- Kit EXT Enteric Bacterial Panel; Catalog # 443812
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 715
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 # 9114557
- UDI (GTIN
- DI+PI): (01)00382904438128 (17)201107(10)9114557(30)1
- Exp: 11/7/2020 Lot # 9126778
- DI+PI): (01)00382904438128 (17)201117(10)9126778(30)1
- Exp: 11/17/2020 Lot # 9129979
- DI+PI): (01)00382904438128 (17)201122(10)9129979(30)1
- Exp: 11/22/2020
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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