VITROS Chemistry Products DGXN Slides --- [REF] 834 3386…

Date

Aug. 22, 2012

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Reason

Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides

Distribution pattern

Worldwide Distribution - US (nationwide)

Quantity

13338 sale units

Codes and lots

Lots from coating 0204, 0205, 0206. A Coating (CTG) is a unique identifier within the Lot Number of some of OCDs products

Recall started

June 28, 2012

Device type

Enzyme Immunoassay, Digitoxin

Root cause (FDA)

Process control

What the company told customers

Ortho Clinical Diagnostics sent an Urgent Field Safety Notice dated June 28, 2012, via US Postal Service Priority Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Immediately discontinue using heparin plasma samples and use only serum samples when processing VITROS DGXN Slides; Notify their laboratory and medical staff of this change and forward the information if the product have been distributed outside of your facility; Replace the pages of their VITROS Instructions for Use Manual with the enclosed Instructions for Use and Table of Contents; and Discontinue using any copies of the VITROS DGXN Slide IFU (Version 7.0).--- On 28 June 2012 an Urgent Field Safety Notice was sent via US Postal Service Priority Mail to all affected Distributors. They were advised of the issue and instructed to discontinue distributing and discard their remaining inventory of VITROS DGXN Slides. --- Foreign affiliates were informed by email on 28 June 2012 of the issue and instructed to notify their consignees of the issue and actions. The letters included a Confirmation of Receipt form to be completed and return. For questions contact Customer Technical Servives at 1-800-421-3311

Recall number

Z-2211-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2211-2012. The agency record governs; check it and the company before acting.