Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2213-2017Class III

Nutrient Gelatin, Acumedia Part Number 7471 A

Neogen Culture Media / initiated 2016-03-23 / Terminated / root cause: labeling and UDI

Acumedia Manufacturers, Inc. began a recall of Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase... on . FDA classified it as Class III and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2213-2017
Classification
Class III
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Neogen Culture Media
Product
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.
Product code
JSG Culture Media, Non-Selective And Non-Differential
Reason for recall
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 tag
labeling and UDI
FDA 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 in commerce
5 units
Distribution
Worldwide - US Nationwide in the state of ME; in the country of ECUADOR
Product codes and lots
PN 7471A, Lot 105550F

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2213-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2213-2017Class IIITerminatedVoluntary: Firm initiated