—#30052

Product

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

FDA product code: JTY — Culture Media, For Isolation Of Pathogenic Neisseria
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot/EXP 3197678/ November 13, 2003*** 3197693/ November 14, 2003*** 3198565/ November 07, 2003*** 3212853/ November 25, 2003*** 3212901/ November 27, 2003*** 3212919/ November 28, 2003*** 3212956/ December 02, 2003*** 3212972/ December 03, 2003***

Why it was recalled

Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species.

Root cause (FDA determination)

Other

Action the firm took

The 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.

Recalling firm

Firm: Becton Dickinson & Co
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Product was sold to domestic distributors and direct shipped end users nationwide including government consignees, and was additionally sold to affiliated international distributors.

Timeline

Recall initiated: 2003-10-10
Posted by FDA: 2003-11-27
Terminated: 2004-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30052. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.