Class 3 Device Recall CYTOSTAIN

• Date Initiated by Firm: February 19, 2015
• Date Posted: March 11, 2015
• Recall Status: Terminated on January 12, 2016
• Recall Number: Z-1264-2015
• Recall Event ID: 70562
• Product Classification: Stain, papanicolau - Product Code HZJ
• 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.
• Code Information: Lot: 313833 Expiration date: 11/2016
• Recalling Firm/ Manufacturer: Richard-Allan Scientific Company; 4481 Campus Dr; Kalamazoo MI 49008-2590
• For Additional Information Contact: Sarah Rickert; 616-385-4466
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.