Device recall: EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended…
Class III FDA enforcement event 80584. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Mislabeled product
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Richard-Allan Scientific Company started this device recall on 4 Jun 2018. The firm address in the FDA record is in Kalamazoo, MI. FDA put the recall in Class III. FDA event 80584 has 1 product record. The first FDA enforcement report date is 22 Aug 2018. The record gives the status Terminated, with the termination date 7 Jun 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution
Recalling firm
Richard-Allan Scientific Company, Kalamazoo, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2749-2018 | 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. | 1,039 cases/40 boxes per case | Class III | Terminated | 22 Aug 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class III
- 4%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Mar 2017 | Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Sh | Device | Class II | 1 |
| 13 Jun 2016 | Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per ca | Device | Class II | 1 |
| 16 Feb 2016 | Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in | Device | Class III | 1 |
| 29 Apr 2015 | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the prepa | Device | Class II | 2 |
| 19 Feb 2015 | Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; | Device | Class III | 1 |
| 17 Sep 2014 | Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examinatio | Device | Class I | 7 |
Official channels
- FDA enforcement report Z-2749-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 80584. https://recallregister.com/fda/iii/80584/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide Distribution
- What quantity of product is in FDA event 80584?
- The FDA record gives this quantity:
1,039 cases/40 boxes per case
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 4% of the 1,074 device events that started in 2018 are in Class III.