Recall Z-1319-2016— Richard-Allan Scientific Company

Class III FDA medical device recall by Richard-Allan Scientific Company, initiated 2016-02-16, terminated 2016-08-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place. Reason: Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside..

Recalling firm

Richard-Allan Scientific Company

Classification

Class III

Status

Terminated

Initiated

2016-02-16

Terminated

2016-08-23

Firm location

Kalamazoo, MI, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.