The Recall Desk
ModerateFDA (Devices)·Z-0528-2019·Announced 2018-12-12

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.

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. 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)
Affected units
54,300

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically: