Recall Z-2221-2017 ยท JSI Culture Media, Selective And Differential
Acumedia Manufacturers, Inc.
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
| Date | Sep 25, 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 | Neogen Corporation sent a Product Notification dated September 25, 2016, to all affected consignees via email. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product. Consignees were informed that an internal corrective action has been initiated and actions have been taken and implemented to prevent this situation from occurring again. The label has been corrected and existing inventory has been relabeled. For questions regarding this recall call 800-234-5333, ext 2362. |
| Quantity | 28 units |
| Distribution | Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.