ClearanceBrief
Recall Z-2749-2018 ยท IFB Cytocentrifuge

Richard-Allan Scientific Company

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.

DateJun 4, 2018
StatusTerminated
ReasonMislabeled product
Root causeLabeling mix-ups
ActionOn 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 marganne.miller@thermofisher.com
Quantity1,039 cases/40 boxes per case
DistributionUS Nationwide Distribution
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.