The Recall Desk
ModerateFDA (Devices)·Z-2321-2019·Announced 2019-08-28

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.

What this means for you

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
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.

See all 19 products in this recall →