Recall Z-1733-2009 ยท JSY Kit, Identification, Mycobacteria
Remel, Inc
Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.
| Date | Aug 14, 2009 (initiated May 6, 2009) |
| Status | Terminated |
| Reason | The plate labeling is incorrect, but the outer box labeling is correct |
| Root cause | Error in labeling |
| Action | The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter. |
| Quantity | 118 packages |
| Distribution | Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.