Z-2749-2018Class III

EZ Single Cytofunnel Brown, A78710004

Name: Z-2749-2018 EZ Single Cytofunnel Brown, A78710004
Creator: Richard-Allan Scientific Company
Published: 2018-06-04
License: https://open.fda.gov/license/

Richard-Allan Scientific LLC / initiated 2018-06-04 / Terminated / root cause: labeling and UDI

FDA source

Richard-Allan Scientific Company began a recall of EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific... on 2018-06-04. FDA classified it as Class III and gives the reason as "Mislabeled product". 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-2749-2018
Classification: Class III
Status: Terminated
Initiated: 2018-06-04
Posted: 2018-08-11
Terminated: 2019-06-07
Recalling firm: Richard-Allan Scientific LLC
Product: EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.
Product code: IFB Cytocentrifuge
Reason for recall: Mislabeled product
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On June 4, 2018, ThermoFisher Scientific issued URGENT MEDICAL DEVICE RECALL notices to customers. Customers were advised to inspect stock, quarantine, safely dispose or return impacted product. Evidence of disposal is required to be sent to Thermo Shandon Limited. If affected product has been used with no issues, please notify Thermo Shandon Limited of the quantity that is unavailable for disposal. Complete and return the Recall Return Response Acknowledgement & Receipt form via email to [email protected]
Quantity in commerce: 1,039 cases/40 boxes per case
Distribution: US Nationwide Distribution
Product codes and lots: Lot # 17269A0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2749-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2749-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-10

Product code IFB

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)