FDA recall Z-0473-2023

Product

BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

Reason for recall

Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.

Key facts

Status

Ongoing

Initiation date

2022-11-21

Report date

2022-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0473-2023