VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro di

FDA device recall Z-1615-2013 · posted 2013-06-27 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.

Action taken

Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 9, 2013 via FedEx or US Priority Mail to all US customers. Foreign Affiliates were notified by e-mail on May 9, 2013 informing them of the issue. Distributors were instructed to notify their customers of the recall. Customers were instructed to discontinue use, discard the affected product, comp[lete and return the attached Confirmation of Recipt Form, and post this notification by each VITROS System. For questions call Customer Service Center at 1-800-828-6316.

Root cause

Employee error

Status

Terminated

Product code

DCK

Quantity affected

Domestic: 4,257; Foreign: 923

Distribution

Worldwide Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Re

Date initiated

2013-05-09

Date posted

2013-06-27

Date terminated

2015-06-12

Location

Rochester, NY