Ortho-Clinical Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-1742-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.

Product Classification:

Class II

Date Initiated: April 6, 2015

Date Posted: June 17, 2015

Recall Number: Z-1742-2015

Event ID: 70917

Reason for Recall:

Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.

Status: Terminated

Product Quantity: 255 units total (131 domestically & 255 internationally)

Code Information:

Product Code: 6802445 Unique Device Identifier No.: 10758750012343

Distribution Pattern:

Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.

Voluntary or Mandated:

Voluntary: Firm initiated