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Terminated

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.

FDA Recall Z-2749-2018 · Posted None

Recalling FirmRichard-Allan Scientific Company
Recall StatusTerminated
Product CodeIFB
Date Initiated2018-06-04
Date Terminated2019-06-07
Product Quantity1,039 cases/40 boxes per case

Reason for Recall

Mislabeled product

Firm 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]

Root Cause

Labeling mix-ups

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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