BD MAX Cdiff EU Reagent Kits Recalled for Improperly Sealed Foil Bags
Becton Dickinson is recalling BD MAX Cdiff EU 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 describes a packaging defect (improperly sealed foil bags) without reporting any illnesses, injuries, or specific adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 4 units of BD MAX Cdiff EU reagent kits, Catalog # 442555, Lot # 9127912. The recall was initiated because the foil bags containing the extraction tubes for these products may not have been sealed properly.
The affected units were distributed to locations in the United States, including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia. The products were also distributed internationally to Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
Consumers and healthcare facilities should stop using the affected kits and contact Becton Dickinson for further instructions or a replacement.
The recalled product
- Product
- Kit BD Max Cdiff EU; Catalog # 442555
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 4
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 (3)
- Lot # 9127912
- UDI (GTIN
- DI+PI): (01)00382904425555 (17)201114(10)9127912(30)1
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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