Device product
Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
Z-1710-2014
Product summary
- Event
- Event 68090
- Status
- Terminated
- Classification
- Class II
- Quantity
- 145 units
- Official record key
device-enforcement:Z-1710-2014
Official wording
Reason: Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.
Code information: Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03
Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom
Derived failure modes
-
Unknown
Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.