Recall Z-0621-2007 ยท JSI Culture Media, Selective And Differential
Remel, Inc.
Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.
| Date | Mar 14, 2007 (initiated Feb 21, 2007) |
| Status | Terminated |
| Reason | False negative results for sorbitol fermenting bacteria such as E. Coli 0157. |
| Root cause | Other |
| 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 | 694/10-pack boxes |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.