Recall Z-0901-2025 ยท LFM Enzyme Immunoassay, Digitoxin
QUIDEL ORTHO
Brand 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 arrhyth
| Date | Jan 10, 2025 (initiated Dec 5, 2024) |
| Status | Open, Classified |
| Reason | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results. |
| Root cause | Device Design |
| Action | 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 eac |
| Quantity | 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, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942610 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) Eastman Kodak Company, Oct 20, 1994 |