BBL Chocolate II Agar- IVD for the isolation and cultivation of… — Class II medical device recall Z-0473-2023
Ongoing recall by Becton Dickinson & Co., reported 2022-12-21, distributed nationwide. Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the
| Recall number | Z-0473-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2022-11-21 |
| Classified | 2022-12-09 |
| Reported by FDA | 2022-12-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IN, PH |
| Quantity | 9,600 units |
| Lot numbers | 0002, 20221125, 2206461 |
| Model numbers | 221267 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0473-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.