Recall Z-2212-2017 ยท JSG Culture Media, Non-Selective And Non-Differential
Acumedia Manufacturers, Inc.
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
| Date | Jun 1, 2017 (initiated Aug 8, 2016) |
| Status | Terminated |
| Reason | Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. |
| Root cause | Error in labeling |
| Action | On 8/8/2016 and 10/6/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product. |
| Quantity | 10 units |
| Distribution | US in the state of IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.