Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-1913-2016)

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 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

Product Classification:

Class II

Date Initiated: April 6, 2016

Date Posted: June 15, 2016

Recall Number: Z-1913-2016

Event ID: 73887

Reason for Recall:

Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

Status: Terminated

Product Quantity: US: 218 units, Foreign: 587 units

Code Information:

Software Version 3.2.2 & below; Serial Numbers J36000012 - J36000933.Unique Device Identifier No. 10758750002979, IVD.

Distribution Pattern:

Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated