| |
Class 3 Device Recall Remel Chocolate Agar |
 |
| Date Initiated by Firm |
September 27, 2004 |
| Date Posted |
October 20, 2004 |
| Recall Status1 |
Terminated 3 on April 25, 2006 |
| Recall Number |
Z-0024-05 |
| Recall Event ID |
30154 |
| Product Classification |
Culture Media, Enriched - Product Code KZI
|
| Product |
Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS. |
| Code Information |
Lot #435902, Exp. 2004-11-04 |
Recalling Firm/
Manufacturer |
Remel, Inc.
12076 Santa Fe Trail Dr
(PO Box 14478, zip 66285-4478)
Lenexa KS 66215-3519
|
| For Additional Information Contact |
Robert Booth
913-895-4007
|
Manufacturer Reason
for Recall |
The product does not perform as intended with some quality control organisms (Haemophilus influenzae)
|
FDA Determined
Cause 2 |
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 in Commerce |
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. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|
