Becton Dickinson Recalls BBL DrySlide PYR Kits Due to Packaging Error
Becton Dickinson is recalling 610 BBL DrySlide PYR Kits because they were placed in incorrect packaging for distribution to laboratories.
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 involves a packaging error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 610 BBL DrySlide PYR Kits, catalog number 231747, lot 2276481, with an expiration date of 09/30/13. The recall is due to in-vitro diagnostic agents being placed into incorrect packaging for distribution to microbiological laboratories.
The affected kits are used as a presumptive diagnostic aid for group A streptococci and group D enterococci bacteria. The recall covers worldwide distribution, including the United States, Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
Microbiological laboratories should stop using the affected kits and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 610
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 (1)
- PYR kit - lot 2276481 with expiration date 09/30/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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