VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Arr

FDA device recall Z-0968-2014 · posted 2014-02-10 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays.

Action taken

Ortho Clinical Diagnostics sent an Important Product Correction Notification dated October 10, 2013 to all affected customer. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to complete and return the attached Confirmation of Receipt form. For questions contact the Customer Technical Services at 1-800-421-3311.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JRB

Quantity affected

6380 units (each unit contains 48 arrays with 10 microcups)

Distribution

Worldwide Distribution - US Nationwide and the countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Republic of Panama, Singapore, Venezuela, England, France, Ger

Date initiated

2013-10-10

Date posted

2014-02-10

Date terminated

2018-05-18

Location

Rochester, NY