The Recall Desk
LowFDA (Devices)·Z-2749-2018·Announced 2018-08-22

Richard-Allan Scientific Recalls Mislabeled EZ Single Cytofunnel Brown Units

Richard-Allan Scientific is recalling 1,039 cases of EZ Single Cytofunnel Brown units due to mislabeling. The recall is voluntary and nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically low severity (score 1 or 2) because it is unlikely to cause adverse health consequences. The specific reason for recall is mislabeling, which aligns with the 'Low' severity criteria for documentation or packaging issues.

Plain-English summary

Richard-Allan Scientific Company is voluntarily recalling 1,039 cases of EZ Single Cytofunnel Brown (A78710004) units. Each case contains 40 boxes. The product is intended for single use with the Thermo Scientific Cytospin.

The recall was initiated because the product was mislabeled. The FDA classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences. The recall covers units distributed nationwide in the United States.

The recall was initiated on June 4, 2018, and was terminated on June 7, 2019. The firm notified customers via letter. Consumers and healthcare facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # 17269A0

Distribution

Distributed nationwide across the United States.