Recall Z-0069-04 ยท JTY Culture Media, For Isolation Of Pathogenic Neisseria
Remel, Inc
Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the label is Remel, Lenexa, KS.
| Date | Oct 24, 2003 (initiated Oct 2, 2003) |
| Status | Terminated |
| Reason | Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae |
| Root cause | Other |
| Action | The recalling firm initiated recall via letter dated 10/2/03 issued regular mail requesting the customer destroy remaining inventory of the affected lot numbers. |
| Quantity | 404/10-pks; 67/15-pks; and 33/100-pkg. cases |
| Distribution | Distribution was made nationwide to facilities with medical laboratories, including military and government facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.