Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use — Class III medical device recall Z-1319-2016
Terminated recall by Richard-Allan Scientific Company, reported 2016-04-13, distributed in AZ, CA, FL, GA, IL, MI, MN, NM…. Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) bu
| Recall number | Z-1319-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Richard-Allan Scientific Company, Kalamazoo, MI, United States |
| Recall initiated | 2016-02-16 |
| Classified | 2016-04-04 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-08-23 |
| Distributed | AZ, CA, FL, GA, IL, MI, MN, NM, NY, OH, TX, UT |
| Countries outside the US | DE, GB |
| Lot numbers | 348248 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1319-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.