Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386

FDA device recall Z-0901-2025 · posted 2025-01-10 · Open, Classified

Recall details

Recalling firm

QUIDEL ORTHO

Reason for recall

Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.

Action taken

On December 5, 2024 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to consignees. REQUIRED ACTIONS - For customers who have VITROS 5,1 FS/4600/5600/XT 3400/XT 7600 Systems: Load ADD DRV 6308 upon receipt. - For customers who have VITROS 250/350 Systems: Please be aware of the lowering of the Interferent Concentration limit from 300 mg/dL to 100 mg/dL at a digoxin concentration of 2.0 ng/mL (2.6 nmol/L). - Complete and return the enclosed Confirmation of Receipt form no later than December 13, 2024. - Save this notification with your User Documentation or post this notification by each VITROS 250/350/5,1 FS/4600/5600/XT 3400/XT 7600 System in your laboratory until the issue has been resolved. - Please forward this notification if the affected product was distributed outside of your facility. - If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Resolution Our investigation to revise the limit at which hemoglobin interference may reach an unacceptable level is ongoing. In the interim we will be issuing a Technical Bulletin to implement the temporary changes to the Sample Indices Threshold default hemolysis limit on the ADD and the hemoglobin Interferent Concentration limit for digoxin listed in the IFU. We will communicate again after our investigation has completed. QuidelOrtho is targeting to have an update by Q1 2025. Contact Information We apologize for the inconvenience this may cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311. To report adverse events, contact your local Global Services Organization. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm, 1-800-332-1088. On December 5, 2024 URGENT PRODUCT CORRECTION NOTIFICATION lette

Root cause

Device Design

Status

Open, Classified

Product code

LFM

Quantity affected

4,417 units (3,358 US, 1,125 OUS)

Distribution

Domestic: Nationwide Distribution International: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portug

Date initiated

2024-12-05

Date posted

2025-01-10

Location

Rochester, NY

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