Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-1074-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Product Classification:

Class II

Date Initiated: December 21, 2015

Date Posted: March 16, 2016

Recall Number: Z-1074-2016

Event ID: 72979

Reason for Recall:

Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

Status: Terminated

Product Quantity: US = 1009; Foreign = 1003

Code Information:

Software Version 3.2 and below; Serial Numbers J56000024 - 56002339

Distribution Pattern:

Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela

Voluntary or Mandated:

Voluntary: Firm initiated