Recall Z-2213-2017 ยท JSG Culture Media, Non-Selective And Non-Differential
Acumedia Manufacturers, Inc.
Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
| Date | Jun 1, 2017 (initiated Mar 23, 2016) |
| Status | Terminated |
| Reason | Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018. |
| Root cause | Error in labeling |
| Action | On 3/23/2016, 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 | 5 units |
| Distribution | Worldwide - US Nationwide in the state of ME; in the country of ECUADOR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.