Becton Dickinson Recalls Phoenix AST-s Indicator Due to Test Aborts
Becton Dickinson is recalling Phoenix AST-s Indicator lots because they cause increased test aborts. The products were distributed to 41 US states and 33 foreign countries.
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, fitting the criteria for a moderate severity score.
Plain-English summary
Becton Dickinson & Co. is recalling 62,880 units of Phoenix AST-s Indicator, Catalog Number 246009. The recall is due to an increased occurrence of test aborts in panels inoculated using certain lots of the indicator solution.
The affected products were distributed to 41 US states, including Alabama, California, and Texas, as well as 33 foreign countries, including Canada, Japan, and Brazil. Specific batch numbers involved in the recall include 8298797, 8254819, and 8254817.
Healthcare facilities and consumers should stop using the affected indicator solution and contact Becton Dickinson for further instructions or a replacement.
The recalled product
- Product
- Phoenix AST-s Indicator, Catalog Number 246009
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 62,880
Distribution
Part of a larger recall action
This product is one of 3 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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