Recall Z-0345-03 ยท JTY Culture Media, For Isolation Of Pathogenic Neisseria
Becton Dickinson & Co.
Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. Catalog # 221267
| Date | Dec 18, 2002 (initiated Nov 18, 2002) |
| Status | Terminated |
| Reason | Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species. |
| Root cause | Other |
| Action | Becton Dickinson notified distributors by fax on 11/18/02 to discard inventory. Firm additionally notified distributors on 11/21/02 to include three additional lots of agar for recall. End users were notified by letter 11/21/02 to discard inventory for replacement, and return reply form. |
| Quantity | 6422 cartons/ 100 plates per carton |
| Distribution | Product was sold to distributors and subsequently distributed to medical facility end users nationwide and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.