Device 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.
Z-2213-2017
Product summary
- Event
- Event 77275
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5 units
- Official record key
device-enforcement:Z-2213-2017
Official wording
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.
Code information: PN 7471A, Lot 105550F
Distribution pattern: Worldwide - US Nationwide in the state of ME; in the country of ECUADOR
Derived failure modes
-
Unknown
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.