BD Max Check-Points CPO IVD Kit Recalled for Improperly Sealed Foil Bags
Becton Dickinson is recalling 130 units of BD Max Check-Points CPO IVD kits because foil bags containing extraction tubes may not be 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential packaging defect (improper sealing) without confirmed adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Becton Dickinson & Co. is recalling 130 units of the BD Max Check-Points CPO IVD EU kit, Catalog # 278102. The recall is due to a manufacturing defect where the foil bags containing extraction tubes may not have been sealed properly.
The affected product is identified by Lot # 9114645. The recall covers distribution across numerous U.S. states, including Alabama, Arizona, California, Florida, New York, and Texas, as well as international locations such as Australia, Canada, China, and Japan.
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. Users of the product should refer to the official FDA recall notice for specific instructions on how to handle the affected units.
The recalled product
- Product
- Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 130
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 # 9114645
- UDI (GTIN
- DI+PI): (01)00180002781029 (17)200719(10)9114645(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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