Recall Z-0015-2015— Richard-Allan Scientific Company
Class I · Terminated
Class I FDA medical device recall by Richard-Allan Scientific Company, initiated 2014-09-17, terminated 2016-10-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The affected lots could have NBF concentrations that are lower or higher than the desired specifications..
- Recalling firm
- Richard-Allan Scientific Company
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-09-17
- Terminated
- 2016-10-27
- Firm location
- Kalamazoo, MI, United States
Product description
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.
Reason for recall
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.