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 D

Hazard

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

Details from the source

Reason for recall: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results. 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, Quantity: 1,541 units (1,125 US, 416 OUS) Lot/code info: Model No 8343386; UDI/GTIN 10758750004782; Coating 0272, expiration date; 01-April-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.

UPC codes

10758750004782

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.