Z-1319-2016 Class III Terminated
FDA device recall Z-1319-2016 was initiated by Richard-Allan Scientific Company on February 16, 2016 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated August 23, 2016). Affected quantity: 29 cases (10 bags per case).
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2016
- Initiation Date
- February 16, 2016
- Termination Date
- August 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 cases (10 bags per case)
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide distribution to AZ , CA , FL , GA , IL , MI , MN , NM , NY , OH , TX , UT and Internationally to Germany and the United Kingdom. 6 distributed to OUS accounts: Germany, and the United Kingdom
Code Information
Product code: 8335 and lot code: 348248