The Recall Desk
HighFDA (Devices)·Z-0473-2023·Announced 2022-12-21

BBL Chocolate II Agar laboratory culture media recalled for nutrient deficiency

BBL Chocolate II Agar culture media manufactured by Becton Dickinson contains reduced nutrients and may cause false negative results in laboratory bacterial identification testing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with potential for false negative results in bacterial identification. While no illnesses or injuries have been reported, the failure to correctly identify Haemophilus could result in missed or delayed diagnosis of patient infections.

Plain-English summary

BBL Chocolate II Agar is a culture medium used in clinical laboratories for the isolation and cultivation of Neisseria bacteria. Certain lots of this product (lot number 2206461, with an expiration date of November 25, 2022, in boxes numbered 0002 through 0097) contain reduced concentrations of Nicotinamide Adenine Dinucleotide and insufficient blood factors to support bacterial growth.

This nutrient deficiency may result in false negative findings when attempting to isolate or identify Haemophilus from clinical specimens. A false negative result can delay diagnosis by failing to identify the pathogen present.

The affected product was distributed worldwide to clinical laboratories in the United States, Canada, India, and the Philippines. Laboratories that have received affected lots should be aware of the potential for false negative results in bacterial identification tests performed with this product.

The recalled product

Product
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Manufacturer
Becton Dickinson & Co.
Hazard
  • false-negative
  • diagnostic-error

Distribution

Distributed nationwide across the United States.