BD Max Enteric Parasite Panel EU Extraction Tube Sealing Defect
Becton Dickinson is recalling BD Max Enteric Parasite Panel EU 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, and the source text describes a potential sealing defect without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 355 units of the BD Max Enteric Parasite Panel EU (Catalog # 442960). The recall is due to a manufacturing defect where the foil bags containing the extraction tubes may not have been sealed properly.
The affected product is identified by Lot # 9106889 and has an expiration date of 11/15/2020. The product was distributed to various 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. It was also distributed to Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
Healthcare facilities and consumers should stop using the affected product and contact Becton Dickinson & Co. for further instructions or a replacement.
The recalled product
- Product
- Kit BD Max Enteric Parasite Panel EU; Catalog # 442960
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 355
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 (4)
- Lot # 9106889
- UDI (GTIN
- DI+PI):(01)00382904429607 (17)201115(10)9106889(30)1
- Exp: 11/15/2020
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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