Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label
FDA device recall Z-0024-05 · posted 2004-10-20 · Terminated
Recall details
- Recalling firm
- Remel, Inc.
- Reason for recall
- The product does not perform as intended with some quality control organisms (Haemophilus influenzae)
- Action taken
- The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot.
- Root cause
- Other
- Status
- Terminated
- Product code
- KZI
- Quantity affected
- 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.
- Date initiated
- 2004-09-27
- Date posted
- 2004-10-20
- Date terminated
- 2006-04-25
- Location
- Lenexa, KS
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