Recall Z-1319-2016 ยท IDT Apparatus, Melting Point, Paraffin
Richard-Allan Scientific Company
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 liq
| Date | Feb 16, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | ThermoFisher sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 15, 2016, to all affected customers. The letter contained the following instructions: If you have the above lot in your possession, please determine whether the bags are labeled as Type 3 (PN 8335) or Type 6 (PN 8336). If the product is labeled as Type 3 (PN 8335) please complete the attached Response form with the quantity in inventory and return the form to Richard-Allan Scientific. The product may be used and no further action is required. If the product is labeled as Type 6 (PN 8336) please complete |
| Quantity | 29 cases (10 bags per case) |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.