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Recall Observatory FDA recall evidence

Device product

Richard-Allan Scientific Bio-Tite Specimen Containers. 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-0015-2015

September 17, 2014

Class I

Product summary

Firm
Richard-Allan Scientific Company
Event
Event 69276
Status
Terminated
Classification
Class I
Quantity
383 cases
Official record key
device-enforcement:Z-0015-2015

Official wording

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

Code information: Product Code: 59601 Lot Number: 300233

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.