Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-1072-2016)

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 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

Product Classification:

Class II

Date Initiated: December 21, 2015

Date Posted: March 16, 2016

Recall Number: Z-1072-2016

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 = 885; Foreign: 3221

Code Information:

Software Version 9.4 and below; Serial Numbers J27000001 - 27004539

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