CLASS III Device recall · Reported 18 Mar 2015 · FDA Enforcement Report

Carton: Richard-Allan Scientific Cyto-stain recalled

Richard-Allan Scientific is recalling Carton: Richard-Allan Scientific Cyto-stain. The recall was initiated on 19 Feb 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot: 313833 Expiration date: 11/2016

Quantity recalled132

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1264-2015
FDA event ID: 70562
Recalling firm: Richard-Allan Scientific, Kalamazoo, MI
Classification: Class III
Status: Terminated
Recall initiated: 19 Feb 2015
FDA classified: 11 Mar 2015
Reported: 18 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

19 Feb 2015	Recall initiated by company
11 Mar 2015	Classified by FDA	+20 days
18 Mar 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

US, Canada and Europe

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot: 313833 Expiration date: 11/2016

Where was it sold?

US, Canada and Europe

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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