Recall Z-0024-05 ยท KZI Culture Media, Enriched
Remel, Inc.
Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.
| Date | Oct 20, 2004 (initiated Sep 27, 2004) |
| Status | Terminated |
| Reason | The product does not perform as intended with some quality control organisms (Haemophilus influenzae) |
| Root cause | Other |
| Action | The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot. |
| Quantity | 4,620 units (308 packages) |
| Distribution | Distribution was made to medical facilities and laboratories located in IA, KS, MO, FL, NY, IL, AR, TX, and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.