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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recall |
|---|---|
| Recall Numbers | Z-1919-2024 |
| Risk Class | Class 2 |
| Recall Qty | 1,160 |
| Classification Date | 2024-05-29 |
| Recall Link | Recall Link. |
| Notes/Alerts | N/A |
| Recall Reason | Potential for the front plexiglass door of the automated slide processing system to break causing potential injury. |
DEVICE
| Manufacturer | Agilent Technologies |
|---|---|
| Model Names | Dako CoverStainer, Dako CoverStainer CPO |
| Model Numbers | CS10030, CS10040, CS10026, CS10026E |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | Microscope Slide Stainer IVD |
| Serial Number(s) | All |
| Lot #/Exp Date(s) | All Lots |
CUSTOMER/PATIENT ACTIONS
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 cover.
2). Confirm that you have received this information by signing and returning enclosed acknowledgement form
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.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Agilent Technology. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
