Class 2 Device Recall Dako CoverStainer, Dako CoverStainer CPO

• Date Initiated by Firm: April 02, 2024
• Date Posted: May 29, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1919-2024
• Recall Event ID: 94439
• Product Classification: Slide stainer, automated - Product Code KPA
• Product: Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
• Code Information: Lot Code: All Lots
• Recalling Firm/ Manufacturer: Agilent Technologies; 815 14th St Sw; Loveland CO 80537-6330
• For Additional Information Contact: Sarah Litton; 669-2557696
• Manufacturer Reason for Recall: There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
• FDA Determined Cause: Device Design
• Action: On April 15, 2024, Agilent Technologies, issued a "Urgent Medical Device Correction" notification to affected consignees. Agilent asked consignees to take the following actions: 1. Monitor your device and contact the service organization in case you discover a problem with the plexiglass on the lower front door. - In case the plexiglass of the lower front door is broken, immediately cease operation of the instrument - Do not remove the lower front door assembly, and do not run the instrument without the cover2.Confirm that you have received this information by signing and returning enclosed acknowledgement form Agilent Agilent is currently improving the design of the assembly to correct the issue. When the new design becomes available, the Agilent Service Organization will contact you and update your device at the next service visit. Please document the information on the enclosed Acknowledgement Form and send to Agilent s Field Action Team at fieldactions@agilent.com. In case of any question, please contact your local sales representative or Agilent service organization. We kindly ask you to inform those who need to be aware of this notification within your organization or any other organization to which the affected product(s) have been transferred. Please ensure that your organization maintains awareness of this notice. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Quantity in Commerce: 1160 devices
• Distribution: Worldwide - US Nationwide distribution in the states of CA, TN, MI, MD, MA, OR, AK, MO, NC, NH, GA, RI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Spain, Italy, Japan, Malaysia, Netherland, New Zealand, Norway, Peru, South Korea, Sweden, Switzerland, Taiwan, The United Kingdom, Algeria, Bulgaria, Costa Rica, Cyrpus, Czech Republic, Ecuador, Egypt, Estonia, Greece, Hungary, India, Iraq, Ireland, Isreal, Kenya, Kuwait, Latvia, Lebanon, Morocco, Oman, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovakia, Thailand, Turkey, Ukraine, United Arab Emirates, Vietnam.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.