ClearanceBrief
Recall Z-0164-04 ยท JTY Culture Media, For Isolation Of Pathogenic Neisseria

Becton Dickinson & Co

Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per carton.

DateNov 27, 2003 (initiated Oct 10, 2003)
StatusTerminated
ReasonMicrobiological media may exhibit reduced colony size of bacteria, Haemophilus species.
Root causeOther
ActionThe recalling firm notified distributors by fax and end users by certified mail on 10/10/03. The recall notice advised consignees of reduced growth of Haemophilus species, and instructed them to discontinue distribution and use and discard product for replacement. The letter requests consignees to respond with replacement units needed.
Quantity7302 cartons
DistributionProduct was sold to domestic distributors and direct shipped end users nationwide including government consignees, and was additionally sold to affiliated international distributors.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.