Z-1319-2016Class III

Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and...

Name: Z-1319-2016 Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and...
Creator: Richard-Allan Scientific Company
Published: 2016-02-16
License: https://open.fda.gov/license/

Richard-Allan Scientific LLC / initiated 2016-02-16 / Terminated / root cause: labeling and UDI

FDA source

Richard-Allan Scientific Company began a recall of Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific"... on 2016-02-16. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1319-2016
Classification: Class III
Status: Terminated
Initiated: 2016-02-16
Posted: 2016-04-04
Terminated: 2016-08-23
Recalling firm: Richard-Allan Scientific LLC
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
Product code: IDT Apparatus, Melting Point, Paraffin
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.
Root cause tag: labeling and UDI
FDA 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 the attached Response form with the quantity in inventory. The product may be used as is or returned to Richard-Allan Scientific. Please indicate on the Response form if the product will be used or a return is desired. Return the completed form to Richard-Allan Scientific. If affected product has been used previously, please complete the attached Response form with the quantity that was used. No further action is required. By returning the attached Acknowledgment Form will facilitate reporting of this matter to the FDA. Customers with questions were instructed to call 269-544-5628.
Quantity in commerce: 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
Product codes and lots: Product code: 8335 and lot code: 348248

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1319-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1319-2016	Class III	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-04

Product code IDT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)