Device product
Richard-Allan Scientific Specimen Transportation System. 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-0013-2015
Product summary
- Event
- Event 69276
- Status
- Terminated
- Classification
- Class I
- Quantity
- 285 cases
- Official record key
device-enforcement:Z-0013-2015
Official wording
Reason: The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Code information: Product Code: 534801 Lot Number: 296986
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
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.