Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Growth Inhibition
Becton Dickinson is recalling 54,300 plates of Trypticase Soy Agar with 5% Sheep Blood because a manufacturing error inhibited the growth of Gram-negative organisms.
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. The hazard is a functional defect (inhibited growth) rather than a direct physical or chemical health hazard, and no injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling 54,300 plates of BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261. The affected product is identified by Lot No. 8221508 and has an expiration date of 2018-11-30.
The recall was initiated because a portion of this single lot was not manufactured in accordance with the internal formulation. This manufacturing deviation resulted in the inhibited growth of Gram-negative organisms, which compromises the product's intended function as a culture medium.
The product was distributed nationwide in the United States, specifically in the states of AL, AR, AZ, CA, CT, FL, GA, HI, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, PA, RI, TX, VA, VT, WA, and WV. Users of this product should stop using the affected lot and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 54,300
Distribution
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