FDA Device recall Z-1319-2016
Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use
- FDA Device
- Class III
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class III recall of Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use by Richard Allan Scientific, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1319-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-02-16 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Richard Allan Scientific |
| Distribution | AZ, CA, FL, GA, IL, MI, MN, NM, NY, OH, TX, UT |
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.
Identifiers
| code_info | Product code: 8335 and lot code: 348248 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1319-2016%22
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