Z-1264-2015Class III

Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT...

Name: Z-1264-2015 Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT...
Creator: Richard-Allan Scientific Company
Published: 2015-02-19
License: https://open.fda.gov/license/

Richard-Allan Scientific LLC / initiated 2015-02-19 / Terminated / root cause: labeling and UDI

FDA source

Richard-Allan Scientific Company began a recall of Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific... on 2015-02-19. FDA classified it as Class III and gives the reason 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1264-2015
Classification: Class III
Status: Terminated
Initiated: 2015-02-19
Posted: 2015-03-11
Terminated: 2016-01-12
Recalling firm: Richard-Allan Scientific LLC
Product: 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.
Product code: HZJ Stain, Papanicolau
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Urgent Medical Device Recall letters sent to Richard Allan distributors and customers. The recall notification includes the reason for the voluntary recall, risk to health, product information and actions to be taken by the distributor/customer.
Quantity in commerce: 132
Distribution: US, Canada and Europe
Product codes and lots: Lot: 313833 Expiration date: 11/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1264-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1264-2015	Class III	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-11

Product code HZJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)