VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and

FDA device recall Z-2211-2012 · posted 2012-08-15 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

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

Action taken

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

Root cause

Process control

Status

Terminated

Product code

LFM

Quantity affected

13338 sale units

Distribution

Worldwide Distribution - US (nationwide)

Date initiated

2012-06-28

Date posted

2012-08-15

Date terminated

2016-05-20

Location

Rochester, NY

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