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Recall Observatory FDA recall evidence

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

January 10, 2014

Class II

Product summary

Firm
Leica Microsystems, Inc.
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

    reason.no_named_rule · v1.0.0

    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.