| Date Initiated by Firm | February 21, 2007 |
|---|
| Date Posted | March 14, 2007 |
|---|
| Recall Status1 |
Terminated 3 on March 06, 2008 |
| Recall Number | Z-0621-2007 |
|---|
| Recall Event ID |
37423 |
| Product Classification |
Agar - Product Code JSI
|
| Product | Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS. |
|---|
| Code Information |
Lot 506069, Exp. 2007/03/20 |
Recalling Firm/
Manufacturer |
Remel, Inc.
12076 Santa Fe Trail Dr
Lenexa KS 66215
|
| For Additional Information Contact | Earleen C. Parks
913-895-4185 |
|---|
Manufacturer Reason
for Recall | False negative results for sorbitol fermenting bacteria such as E. Coli 0157. |
|---|
FDA Determined
Cause 2 | Other |
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| Action | Recall letters dated 2/19/07 were issued on 2/21/07 via regular mail explaining the reason for recall and requesting all remaining inventory of the affected lot be discarded. A Product Inventory Checklist was enclosed to indicate the amount of inventory the customer discarded. This was to be returned via FAX or mail in the return envelope provided. |
|---|
| Quantity in Commerce | 694/10-pack boxes |
|---|
| Distribution | Nationwide. |
|---|
| 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.
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