Ortho-Clinical Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-1728-2015)

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 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing.

Product Classification:

Class II

Date Initiated: April 6, 2015

Date Posted: June 17, 2015

Recall Number: Z-1728-2015

Event ID: 70918

Reason for Recall:

Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.

Status: Terminated

Product Quantity: 2,387 units Total (987 domestically & 1400 internationally)

Code Information:

Product Code: 6801375, 6801890 Unique Device Identifier Numbers: 10758750001132, 10758750001644

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