BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Reported: December 21, 2022 Initiated: November 21, 2022 #Z-0473-2023
Product Description
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.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 9,600 EA
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267. Recalled by Becton Dickinson & Co.. Units affected: 9,600 EA.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 21, 2022. Severity: Moderate. Recall number: Z-0473-2023.
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