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Recall Observatory FDA recall evidence

Device product

Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Z-0014-2015

September 17, 2014

Class I

Product summary

Firm
Richard-Allan Scientific Company
Event
Event 69276
Status
Terminated
Classification
Class I
Quantity
80 cases
Official record key
device-enforcement:Z-0014-2015

Official wording

Reason: The affected lots could have NBF concentrations that are lower or higher than the desired specifications.

Code information: Product Code: LC-0060 Lot Number: 300445

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The affected lots could have NBF concentrations that are lower or higher than the desired specifications.