Recall Z-2213-2017— Acumedia Manufacturers, Inc.
Class III · Terminated
Class III FDA medical device recall by Acumedia Manufacturers, Inc., initiated 2016-03-23, terminated 2017-06-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Acumedia Manufacturers, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-03-23
- Terminated
- 2017-06-02
- Firm location
- Lansing, MI, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.