BD MAX Enteric Bacterial Panel Extraction Tube Sealing Defect Recall
Becton Dickinson is recalling BD MAX Enteric Bacterial Panel 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 packaging defect (improper sealing) without reporting any illnesses, injuries, or specific clinical harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 994 units of the BD MAX Enteric Bacterial Panel EU (Catalog # 442963). The recall involves specific lots with expiration dates in October and November 2020. The product was distributed across numerous U.S. states and internationally to countries including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
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 is classified as an FDA Class II recall.
Healthcare facilities and consumers should stop using the affected kits and contact Becton Dickinson for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 994
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 (10)
- Lot # 9085672
- UDI (GTIN
- DI+PI):(01)00382904429638 (17)201011(10)9085672(30)1
- Exp:10/11/2020 Lot # 9085673
- DI+PI):(01)00382904429638 (17)201011(10)9085673(30)1
- Exp:10/11/2020 Lot # 9106961
- DI+PI): (01)00382904429638 (17)201011(10)9106961(30)1
- Exp:10/11/2020 Lot # 9106962
- DI+PI): (01)00382904429638 (17)201102(10)9106962(30)1
- Exp:11/2/2020
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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