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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products DGXN Slides

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 Class 2 Device Recall VITROS Chemistry Products DGXN Slidessee related information
Date Initiated by FirmDecember 05, 2024
Date PostedJanuary 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0901-2025
Recall Event ID 95904
510(K)NumberK942610 
Product Classification Enzyme immunoassay, digitoxin - Product Code LFM
ProductBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. One sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit. Component: No, not a component
Code Information Model No 8343386; UDI/GTIN 10758750004782; Coating 0271, expiration date; 01-March-2025 The scope of this recall is limited to consignees who received VITROS Chemistry Products DGXN slides in the last 18 months. This will include in-date lots manufactured from coatings (production formulation) 0271 and/or 0272. Of the in date product, the latest expiration date is listed for the coating.
Recalling Firm/
Manufacturer		 QUIDEL ORTHO
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactJoe Falvo
585-4533452
Manufacturer Reason
for Recall		Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
FDA Determined
Cause 2		Device Design
ActionOn 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
Quantity in Commerce4,417 units (3,358 US, 1,125 OUS)
DistributionDomestic: Nationwide Distribution International: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom,
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = LFM
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