Food, drugs, devices › Richard-Allan Scientific Company
Device recall: Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016;
FDA enforcement event 70562 is a device recall by Richard-Allan Scientific Company of Kalamazoo, MI, initiated 19 Feb 2015 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 12 Jan 2016. Initiation: voluntary: firm initiated. Richard-Allan Scientific Company has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Richard-Allan Scientific Company, Kalamazoo, MI.
Reason for recall
"The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain."
Distribution
"US, Canada and Europe"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1264-2015 | Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific. | 132 | Class III | Terminated | 18 Mar 2015 |
Context
Other enforcement events for Richard-Allan Scientific Company
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Jun 2018 | EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for | Device | Class III | 1 |
| 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 |
| 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 |
All 7 events for Richard-Allan Scientific Company
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US, Canada and Europe"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Jan 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.